[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"esophageal-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:esophageal-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,233,0,25,[9,46,76,122,157,178,202,227,254,283,313,345,373,412,436,467,490,526,554,578,601,634,680,702,726],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652863","phase-2-study-of-adebrelimab-combined-with-thymalfasin-and-chemotherapy-for-neoadjuvant-treatment-of-esophageal-cancer-100652863",false,"NCT07780721","Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer","Exploratory, Single-Arm, Multicenter Clinical Study of Adebrelimab Combined With Thymalfasin and Chemotherapy as Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Has signed the written informed consent form and voluntarily participates in this study;\n* Aged 18-80 years, male or female;\n* Histopathologically or cytologically confirmed esophageal squamous cell carcinoma;\n* Clinical stage: cT1b-cT2N+M0 or cT3-cT4a any N M0;\n* Has at least one measurable lesion (per RECIST Version 1.1: the measurable lesion has a longest diameter ≥10 mm on spiral CT scan, or a malignant lymph node with short-axis diameter ≥15 mm);\n* Expected to achieve R0 resection;\n* ECOG Performance Status (PS) 0-1 (see Appendix 1);\n* Has not received any prior anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc.;\n* Plans to receive surgical resection after completion of neoadjuvant therapy;\n* No contraindications to surgery.\n* Adequate organ function as specified below:\n\n  1. Hematology laboratory values (No blood products, hematopoietic growth factors, leukopoietic agents, thrombopoietic agents or anti-anemia medications are permitted within 14 days prior to the first study drug administration):\n\n     White blood cell count ≥ 3.0 × 10⁹\u002FL Absolute neutrophil count ≥ 1.0 × 10⁹\u002FL Platelet count ≥ 80 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL\n  2. Serum chemistry:\n\n     Total bilirubin ≤ 1.5 × ULN Alanine transaminase (ALT) ≤ 2.5 × ULN; Aspartate transaminase (AST) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula, see Appendix 2)\n  3. Coagulation function:\n\nInternational normalized ratio (INR) ≤ 1.5 × ULN Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN\n\n* Female subjects of reproductive potential must have a negative serum or urine pregnancy test within 72 hours prior to initiation of study drug, and must use effective contraception (e.g., intrauterine device, oral contraceptives, condoms) throughout the study and for at least 3 months after the last dose of study drug. Male subjects with female partners of reproductive potential must use effective contraception throughout the study and for 3 months after the last dose.\n* Subjects with good compliance and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n* Tumor invades adjacent organs of the esophageal lesion (major arteries or trachea);\n* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n* Poor nutritional status with BMI \\\u003C 18.5 kg\u002Fm². Subjects whose nutritional status is corrected by symptomatic nutritional support prior to enrollment may be considered for inclusion upon assessment by the principal investigator;\n* History of allergy to any component of monoclonal antibodies, adebrelimab, thymalfasin, paclitaxel, carboplatin or other platinum agents;\n* Previously received or currently receiving any of the following treatments:\n\n  1. Any anti-tumor radiotherapy, chemotherapy, immunotherapy, targeted therapy or other anti-neoplastic agents;\n  2. Immunosuppressive agents or systemic corticosteroids administered for immunosuppressive purposes (prednisone \\>10 mg\u002Fday or equivalent dose) within 2 weeks prior to the first study drug administration. Inhaled or topical steroids, and corticosteroid replacement therapy (prednisone \\>10 mg\u002Fday or equivalent dose) are permitted in the absence of active autoimmune disease;\n  3. Live attenuated vaccines administered within 4 weeks prior to the first study drug administration;\n  4. Major surgery or severe trauma within 4 weeks prior to the first study drug administration.\n* Active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subjects receiving hormone replacement therapy may be enrolled). Subjects with psoriasis or childhood asthma\u002Fallergies completely resolved without any intervention in adulthood can be considered eligible; patients requiring medical intervention with bronchodilators are excluded.\n* History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, history of solid organ transplantation or allogeneic bone marrow transplantation;\n* Poorly controlled cardiac signs or diseases, including but not limited to: (1) NYHA Class II or higher heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or still poorly controlled after intervention.\n* Severe infection (CTCAE Grade \\>2) within 4 weeks before the first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Active pulmonary inflammation indicated by baseline chest imaging; subjects presenting with signs and symptoms of infection within 14 days before first dosing or requiring oral\u002Fintravenous antibiotics, except for prophylactic antibiotic use.\n* Active pulmonary tuberculosis confirmed by medical history or CT scan; history of active pulmonary tuberculosis within 1 year before enrollment; or history of active pulmonary tuberculosis more than 1 year previously without standardized treatment.\n* Hereditary bleeding diathesis or coagulation disorders. Clinically significant bleeding events or definite bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ≥++.\n* Diagnosis of another malignant tumor within 5 years prior to the first study drug administration, except malignancies with low risk of metastasis or death (5-year survival rate \\>90%). Fully treated basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of cervix, etc., may be considered for enrollment.\n* Pregnant or breastfeeding women.\n* Any other conditions judged by the investigator that may force premature study discontinuation, such as other severe diseases (including psychiatric disorders) requiring combined medication, alcohol abuse, drug abuse, family or social factors that may affect subject safety or compliance.","ALL","18 Years","80 Years",{"count":21,"type":22},31,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.",[28],"Esophageal Cancer",[30,31,32,28],"Chemotherapy","Adebrelimab","neoadjuvant treatment","NOT_YET_RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":22},"2026-08-30",{"date":41,"type":22},"2029-02-01",{"name":43,"class":44},"The Affiliated Hospital of Putian University","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100636142","exercise-training-after-upper-gastrointestinal-cancer-surgery-100636142","NCT07561840","Exercise Training After Upper Gastrointestinal Cancer Surgery","Exercise and Cardiorespiratory Fitness Improvement Through Supervised Training in Upper Gastrointestinal Cancer Surgery Patients (EXCITING-UGI)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with esophageal or gastric cancer\n* Received curative surgery\n* 6 ± 2 weeks after surgery\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Communication difficulties\n* Poor general status\n* Undergone combined laryngopharyngectomy\n* Unsuitable for evaluation or exercise intervention\n* Unsuitable for the study as determined by the primary physician",{"count":54,"type":22},171,[56],"NA","This randomized controlled trial aims to determine the optimal exercise intensity for improving postoperative recovery in patients with upper gastrointestinal cancer. Participants who have undergone curative surgery will be randomly assigned to high-intensity interval training (HIIT), low-intensity continuous training (LICT), or usual care. The exercise interventions will be performed under supervision three times per week for eight weeks. The primary outcome is peak oxygen uptake (VO₂peak), assessed using cardiopulmonary exercise testing. Secondary outcomes include physical function, body composition, patient-reported outcomes, and biological and mechanistic markers such as inflammatory biomarkers, muscle-related factors, and gut microbiota. This study will also explore potential mechanisms underlying exercise-induced adaptations and their association with clinical outcomes.",[28,59,60],"Gastric Cancer (Diagnosis)","Upper Gastrointestinal Cancer",[62,63,64,65,66],"upper gastrointestinal cancers","exercise","high-intensity interval training","randomized controlled trial","exercise oncology","RECRUITING",{"date":36,"type":37},{"date":70,"type":37},"2026-05-15",{"date":72,"type":22},"2029-11",{"name":74,"class":44},"Kansai Medical University",2,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":101,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":121},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":84,"type":22},740,[25],"This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[88,89,90,91,92,93,94,95,28,96,97,98,99,100],"Advanced Solid Tumor","Melanoma","Head and Neck Cancer","Gastric Cancer","Ovarian Carcinoma","Cervical Cancer","Endometrial Cancer","Bladder Cancer","Pancreatic Carcinoma","Prostate Cancer","Non-small Cell Lung Cancer (NSCLC)","Lung Cancer","Breast Cancer",[88,89,90,91,102,103,104,105,106,107,108,109,110,111,99,100],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402","2026-08-19",{"date":36,"type":37},{"date":115,"type":37},"2024-02-26",{"date":117,"type":22},"2028-10-10",{"name":119,"class":120},"Daiichi Sankyo","INDUSTRY",86,{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":132,"studyType":133,"phases":4,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100652712","nomad-gi-molecular-guided-non-operative-management-and-organ-preservation-strategy-after-precision-therapy-in-gastrointestinal-cancers-100652712","NCT07775859","NOMAD-GI: Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers","Safety and Efficacy of Molecular-guided Non-operative Management and Organ Preservation Strategy After Precision Therapy in Gastrointestinal Cancers: A Single-center Bidirectional Cohort Study","NOMAD-GI","Inclusion Criteria:\n\n1. Adults aged 18 years or older at the time of study enrollment.\n2. Histologically confirmed gastrointestinal malignancy, including gastric cancer, gastroesophageal junction cancer, esophageal cancer, or colorectal cancer.\n3. Presence of at least one molecular biomarker that may support selection of precision therapy, including but not limited to:\n\n   * Mismatch repair deficiency or microsatellite instability-high (dMMR\u002FMSI-H);\n   * Pathogenic or likely pathogenic POLE or POLD1 mutation;\n   * High programmed death ligand 1 combined positive score (PD-L1 CPS), when applicable to the tumor type and treatment strategy;\n   * Tumor mutational burden-high (TMB-H);\n   * Epstein-Barr virus-positive status (EBV-positive), when applicable;\n   * Human epidermal growth factor receptor 2 (HER2) positivity;\n   * Claudin 18.2 (CLDN18.2) positivity;\n   * Fibroblast growth factor receptor 2 (FGFR2) alteration;\n   * Mesenchymal-epithelial transition factor (MET) amplification or other actionable MET alteration;\n   * Neurotrophic tyrosine receptor kinase (NTRK) gene fusion;\n   * Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation;\n   * Other clinically actionable molecular alterations recognized according to contemporary clinical practice.\n4. Receipt of molecular biomarker-guided precision therapy before assessment for non-operative management or organ-preservation strategy. Precision therapy may include immune checkpoint inhibitor therapy, targeted therapy, or a combination of systemic therapies according to the participant's tumor type, molecular profile, clinical stage, and standard clinical practice.\n5. After completion or adequate exposure to precision therapy, achievement of a favorable clinical response that may support consideration of non-operative management or organ-preservation strategy, including clinical complete response (cCR), near-complete response (near-cCR), major tumor regression, or other predefined favorable response categories.\n6. Multidisciplinary team (MDT) evaluation has been performed to determine whether non-operative management, local treatment, organ-preservation strategy, or radical surgery is appropriate.\n7. Adequate clinical information is available for assessment of treatment response, including appropriate imaging, endoscopic evaluation, pathological evaluation, or other clinically indicated examinations.\n8. Ability and willingness to comply with the predefined surveillance and follow-up schedule.\n9. For the prospective cohort, written informed consent is obtained before enrollment and study-specific data collection.\n10. For the retrospective cohort, eligible clinical data are available in the institutional medical records and may be used according to institutional ethics approval and applicable regulations.\n\nExclusion Criteria:\n\n1. Uncontrolled progressive metastatic disease or clinical deterioration that precludes evaluation for the study treatment strategy.\n2. Patients who are unable to undergo appropriate clinical, radiological, endoscopic, or pathological assessment required for response evaluation or follow-up.\n3. Previous treatment history or concurrent medical conditions that, in the judgment of the multidisciplinary team, preclude reliable assessment of tumor response or implementation of the predefined surveillance strategy.\n4. Severe comorbidities or medical conditions that make continued follow-up or additional treatment evaluation clinically inappropriate.\n5. Inability or unwillingness to comply with the predefined follow-up schedule.\n6. Withdrawal of informed consent for prospective participants.\n7. Insufficient clinical information to determine eligibility, treatment response, treatment strategy, or follow-up outcomes.\n8. Patients with conditions that require immediate radical surgery or other urgent treatment according to multidisciplinary clinical assessment and who cannot safely undergo the predefined study evaluation.",{"count":131,"type":22},200,"3 Months","OBSERVATIONAL","The NOMAD-GI study is a single-center, bidirectional cohort study designed to evaluate the safety and efficacy of molecular biomarker-guided non-operative management (NOM) and organ preservation strategies after precision therapy in patients with gastrointestinal cancers.\n\nPatients with actionable molecular biomarkers, including dMMR\u002FMSI-H, POLE mutation, PD-L1 high expression, tumor mutational burden-high (TMB-H), Epstein-Barr virus positivity (EBV+), HER2 positivity, CLDN18.2 positivity, and other actionable genomic alterations, will be enrolled.\n\nAfter immune checkpoint inhibitor or targeted therapy, patients achieving favorable clinical responses will undergo multidisciplinary team (MDT) evaluation and receive either non-operative management, local treatment, or radical surgery according to individualized treatment decisions.\n\nThe study aims to establish a molecular-driven organ preservation paradigm for gastrointestinal cancers and evaluate whether NOM can provide comparable oncological outcomes while improving functional outcomes and quality of life.",[136,91,137,28,138],"Gastrointestinal Cancer","Gastroesophageal Junction Cancer","Colorectal Cancer",[140,141,142,143,144,145,146,147,148],"Precision oncology","Molecular biomarkers","Gastrointestinal cancer","Non-operative management","Organ preservation","Immunotherapy","Targeted therapy","Watch and wait","Multidisciplinary treatment","2026-08-18",{"date":34,"type":37},{"date":152,"type":22},"2026-09-01",{"date":154,"type":22},"2031-09-01",{"name":156,"class":44},"Peking University Cancer Hospital & Institute",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":45},"100652142","phase-2-concurrent-immunotherapy-and-systemic-therapy-with-stereotactic-body-radiation-therapy-sbrt-for-stage-iv-cancers-coinsss-iv-100652142","NCT07770100","Concurrent Immunotherapy and Systemic Therapy With Stereotactic Body Radiation Therapy (SBRT) for Stage IV Cancers (COINSSS IV)","Inclusion Criteria:\n\n* Histologically proven advanced or stage IV head \\& neck, non-small cell lung cancer, cervical, esophageal, gastric, and gastroesophageal cancer at least 6 metastases that are eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites with at least 1 other lesion meeting RECIST criteria of which this additional lesion not be treated with SBRT (biopsies performed for diagnosis are standard of care).\n* At least 6 metastases eligible for SBRT comprising: lung, liver, adrenal glands, bone, and lymph node sites\n* The 1 irradiated lesion must have a max point dose of 5Gy or less.\n* Eligible for Immunotherapy for an FDA-approved indication as defined in section 6.1. NOTE: No limit is placed on prior systemic treatment unless it affects the eligibility for administration of immune checkpoint inhibitor therapy.\n* If prior treatment with chemotherapy or radiotherapy or surgery has occurred: Prior chemotherapy or radiation must have concluded \\> 21 days prior to the start of study treatment. Exception: study treatment can start within 2-3 days following GKS \\[gamma knife surgery\\] or whole brain radiation therapy \\[ WBRT\\], as long as patient is not experiencing ongoing\u002Fresidual AE's related to GKS or WBRT at discretion of treating physician.\n* First Line immunotherapy-based treatments only. The patient may have received prior cycles of immunotherapy, but has to be on the first line of immunotherapy-based treatments.\n* If non-small cell lung cancer patient with pembrolizumab, PD-L1 testing CPS score \\> or = to 50% will have to be shown\n* If cervical cancer patient on secondary line therapy with pembrolizumab, CPS score of \\> or = to 1 will have to be done. Please note, second line therapy with pembrolizumab is only allowed if the patient's first line of therapy did NOT include immunotherapy.\n* If non-small cell lung cancer on first line ipilimumab in combination with nivolumab, PD-L1 of 1% and negative epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.\n* If pembrolizumab is given for a gastric cancer, a PD-L1 expression (CPS =1) will need to be shown\n* If pembrolizumab is given as a single agent treatment after progression of one prior systemic therapy agent for esophageal or gastroesophageal squamous cell carcinoma histology, a PD-L1 (CPS=1) expression will have to be shown.\n* ECOG Performance Status 0 - 1 (see Appendix A).\n* Life expectancy \\> or equal to 6 months.\n* Adequate organ and bone marrow function prior to study treatment as defined by: Thresholds for lab values prior to initiation of study treatment.\n* ANC \\> or equal to 1,000\u002Fmm3\n* Platelets \\> or equal to 100,000\u002Fmm3\n* Total bilirubin \\\u003C or equal to or equal to 1.5 x ULN\n* AST and ALT - With hepatic metastasis, \\\u003C or equal to or equal to 5 x ULN. If no hepatic metastasis, \\\u003C or equal to 2.5 times x ULN\n* Creatinine Or Creatinine Clearance \\\u003C or equal to 1.5 x ULNand\u002For CrCl \\> or equal to 30ml\u002Fmin (per 24-hour urine collection) or calculated according to the Cockcroft-Gault formula (Appendix B)\n* No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for the past 3 years.\n* Non-pregnant and non-nursing women -Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.\n* Women of childbearing potential and men must agree to use adequate contraception methods prescribed their the patients primary care physician, urologist, or obstetrician\u002Fgynecologist prior to study entry and for the duration of study participation.\n* Subjects should use adequate birth control for at least 3 months after the last administration of immune checkpoint inhibitors.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Presence of \\\u003C or equal to 5 sites amenable to SBRT\n* Ineligible for immune checkpoint inhibitors based on package insert of the chosen immune checkpoint inhibitor\n* No more than 7 metastatic sites to an organ, defined as liver, left lung, right lung, single anatomically bone site (e.g. femur, humerus, single vertebral body).\n\nNOTE: Multiple different vertebral bodies are allowed.\n\n* Peritoneal involvement, at the discretion of the study PI. NOTE: Peritoneal metastasis does not exclude GI nor cervical cancer, except in cases where there is a separate focus of spread to the peritoneum.\n* Presence of liver cirrhosis of any grade prohibits SBRT to the liver. NOTE: Pt can enroll to trial if receiving SBRT to other non-liver metastatic sites.\n* A plan that cannot meet organ at risk tolerance (as defined in section 6.7.2.1) Auto-immune diagnosis Medications prohibited while receiving concurrent SBRT: gemcitabine, Adriamycin, VEGF or BRAF inhibitors.\n\nNOTE: However, if the patient is on the prohibited agent(s), the patient is still eligible for the trial so long as the prohibited agent can safely be held for at least 1 month before starting SBRT, during SBRT, and 1 month after completion of SBRT.\n\n-Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury (injury requiring immediate surgical intervention or involving loss of consciousness) within 14 days prior to registration or those patients who receive a nonCNS minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 3 days prior to registration.\n\nNOTE: There is no waiting period for central line placement. There is a 7-day window for recovery prior to registration for patients who underwent stereotactic biopsy of the brain.\n\n* Active clinically serious infection \\> CTCAE Grade 2.\n* Serious non-healing wound, ulcer or bone fracture.\n* Uncontrolled inter-current illness. This includes, but is not limited to: ongoing or active infection; symptomatic congestive heart failure (NYHA class III or IV); unstable angina pectoris or new onset angina that began within the last 3 months; cardiac ventricular arrhythmias requiring anti-arrhythmic therapy; thrombotic\u002F embolic events such as cerebrovascular accident, including transient ischemic attacks within the past 6 months;\n* Uncontrolled hypertension defined as systolic blood pressure \\>150 mmHg or diastolic pressure \\> 90 mmHg, despite optimal medical management; Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C; Known Grade 3 or 4 neurotoxicity.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of ICI.\n\nNote: Patients, if randomized, should not receive live vaccine while receiving ICI and up to 30 days after the last dose of ICI.\n\n-Inclusion of Women and Minorities - Consistent with NIH policy, both men and women of all races and ethnic groups are eligible for this trial.","99 Years",{"count":165,"type":22},35,[25],"This is a Phase II clinical study for people with stage IV cancer. The study will evaluate the use of stereotactic body radiation therapy (SBRT), a type of focused radiation treatment, together with immunotherapy-based treatment. SRBT will be used to treat multiple areas of cancer that have spread to other parts of the body. The study will evaluate whether this treatment approach can be safely given while patients continue their planned cancer treatment and may help control their cancer.",[90,169,93,28,170],"Non-Small Cell Lung Cancer","Gastric Cancer (GC)",{"date":34,"type":37},{"date":173,"type":22},"2026-10-01",{"date":175,"type":22},"2040-02-28",{"name":177,"class":44},"Mark Bernard",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":45},"100610059","phase-2-liquid-nitrogen-spray-cryotherapy-prior-to-neoadjuvant-systemic-therapy-in-esophageal-adenocarcinoma-100610059","NCT07222657","Liquid Nitrogen Spray Cryotherapy Prior to Neoadjuvant Systemic Therapy in Esophageal Adenocarcinoma","Phase 2 Randomized Trial Of Liquid Nitrogen Spray Cryotherapy Prior To Neoadjuvant Systemic Therapy In Locally Advanced Esophageal Adenocarcinoma","Inclusion Criteria:\n\n* Adults with locally advanced EAC who are expected to receive FLOT +\u002F-Durvalumab will be eligible to participate.\n* Locally advanced esophageal cancer is defined as TNM stages T1N+M0 or T2-T4aNanyM0, as defined by endoscopic ultrasound (EUS) and PET-CT.\n\nExclusion Criteria:\n\n* Inability to pass the orogastric decompression tube into the stomach\n* Coagulopathy (INR \\> 2 or platelet count \\\u003C 50,000 per cubic millimeter)\n* Inability to provide informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status \\> 2\n* Risk of thrombosis is determined to be too high to hold anti-platelets (other than aspirin) or anticoagulants prior to the procedure.",{"count":186,"type":22},40,[25],"This research study is for people who have locally advanced esophageal adenocarcinoma and are expected to receive chemotherapy. The purpose of this study is to compare the effectiveness of Liquid Nitrogen Spray Cryotherapy (LNSC) in addition to chemotherapy versus chemotherapy alone in the treatment of esophageal adenocarcinoma. LNSC is an FDA approved device that works by using liquid nitrogen to rapidly cool cancerous tissue causing cell damage. Participants in this study will be randomly assigned to either the \"LNSC group\" or the \"No-LNSC group.\" Participants in the \"LNSC group\" will undergo 2 sessions of LNSC through an upper endoscopy. Participants in the \"No-LNSC group,\" may undergo an endoscopy if needed for symptoms such as difficulty swallowing. Participation in the research will last about 4 months.",[190,28],"Esophageal Adenocarcinoma",[192,193],"Liquid Nitrogen Spray Cryotherapy","LNSC","2026-08-17",{"date":149,"type":37},{"date":197,"type":37},"2026-06-10",{"date":199,"type":22},"2027-09",{"name":201,"class":44},"Case Comprehensive Cancer Center",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":223,"leadSponsor":225,"locationsCount":45},"100652197","phase-2-an-exploratory-clinical-study-of-accurate-efficacy-assessment-of-neoadjuvant-immunotherapy-in-locally-advanced-esophageal-squamous-cell-carcinoma-based-on-68ga-fapi-68ga-fibroblast-activation-protein-inhibitorf-fdg-2-deoxy-2-ffluoro-d-glucose-dual-imaging-100652197","NCT07770672","An Exploratory Clinical Study of Accurate Efficacy Assessment of Neoadjuvant Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma Based on 68Ga-FAPI ([68Ga] Fibroblast Activation Protein Inhibitor)\u002F¹⁸F-FDG (2-Deoxy-2-[¹⁸F]Fluoro-D-glucose) Dual Imaging","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Voluntarily agree to participate in the study and provide written informed consent.\n2. Histologically or cytologically confirmed esophageal squamous cell carcinoma.\n3. Thoracic esophageal cancer assessed by computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography\u002Fcomputed tomography (PET\u002FCT), or other appropriate imaging, with clinical stage II to IVA disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.\n4. Considered by a surgeon to be suitable for an R0 resection and planned to undergo surgery after completing neoadjuvant treatment.\n5. Undergo both 18F-FDG and 68Ga-FAPI PET\u002FCT imaging at baseline. For Stage 2, the participant's 18F-FDG and 68Ga-FAPI PET\u002FCT parameters must meet the criteria of the prediction model for lack of pathologic complete response (non-pCR).\n6. Aged 18 to 75 years, inclusive, with no restriction based on sex.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n8. No previous antitumor treatment for esophageal cancer, including radiotherapy, chemotherapy, surgery, or other antitumor treatment.\n9. No contraindication to surgery.\n10. Adequate major organ function, as defined by all of the following:\n\n    1. Hematologic function. No blood components, hematopoietic growth factors, leukocyte-elevating agents, platelet-elevating agents, or medications used to correct anemia are permitted within 14 days before the first administration of study treatment:\n\n       * Absolute neutrophil count ≥1.5 × 10\\^9\u002FL;\n       * Platelet count ≥100 × 10\\^9\u002FL;\n       * Hemoglobin ≥90 g\u002FL.\n    2. Biochemical function:\n\n       * Total bilirubin ≤1.5 × the upper limit of normal (ULN);\n       * Alanine aminotransferase (ALT) ≤2.5 × ULN and aspartate aminotransferase (AST) ≤2.5 × ULN;\n       * Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin, calculated using the Cockcroft-Gault formula.\n    3. Coagulation function:\n\n       * International normalized ratio (INR) ≤1.5 × ULN;\n       * Activated partial thromboplastin time (aPTT) ≤1.5 × ULN.\n    4. Pulmonary function:\n\n       * Forced expiratory volume in 1 second (FEV1) ≥1.2 L;\n       * FEV1 percentage of predicted value (FEV1%) ≥50%;\n       * Diffusing capacity of the lung for carbon monoxide (DLCO) ≥50%.\n11. A female participant of childbearing potential must have a negative serum pregnancy test within 72 hours before the first administration of study treatment, must not be breastfeeding, and must agree to use a highly effective method of contraception with an annual failure rate of less than 1%, such as an intrauterine device, oral contraceptive, or condom, throughout the study and until 2 months after the last dose of adebrelimab or 6 months after the last dose of chemotherapy, whichever is longer. A male participant with a female partner of childbearing potential must be surgically sterile or agree to use an effective method of contraception throughout the study and until 2 months after the last dose of adebrelimab or 3 months after the last dose of chemotherapy, whichever is longer. Sperm donation is not permitted during the study.\n12. Able and willing to comply with the study procedures and follow-up requirements.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Obvious invasion by the tumor or involved lymph nodes into organs adjacent to the esophageal lesion, including the pleura, pericardium, azygos vein, diaphragm, peritoneum, major arteries, vertebral body, or trachea.\n2. Supraclavicular lymph node metastasis.\n3. Diagnosis of another malignant tumor within 5 years before the first administration of study treatment, except for a malignancy with a low risk of metastasis or death and an expected 5-year survival rate greater than 90%. Participants with adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or a similar malignancy may be considered eligible.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n5. Poor nutritional status, defined as a body mass index (BMI) of less than 18.5 kg\u002Fm2. A participant whose nutritional status is corrected through appropriate nutritional support before the initiation of treatment may still be considered eligible following assessment by the principal investigator.\n6. History of an allergic reaction to a monoclonal antibody.\n7. Receipt of any tumor-directed radiotherapy, chemotherapy, or other antitumor medication.\n8. Use of immunosuppressive medication or systemic corticosteroid treatment for an immunosuppressive purpose within 2 weeks before the first administration of study treatment at a dose greater than 10 mg\u002Fday of prednisone or an equivalent dose. In the absence of an active autoimmune disease, inhaled or topical corticosteroids and adrenal corticosteroid replacement at a dose greater than 10 mg\u002Fday of prednisone or an equivalent dose are permitted.\n9. Receipt of a live attenuated vaccine within 4 weeks before the first administration of study treatment.\n10. Major surgery or severe trauma within 4 weeks before the first administration of study treatment.\n11. Any active autoimmune disease or history of an autoimmune disease, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism. Participants with hypothyroidism may be considered eligible after hormone replacement therapy. Participants with psoriasis or childhood asthma or allergy that has completely resolved and requires no intervention during adulthood may be considered eligible; however, participants requiring medical intervention with a bronchodilator are not eligible.\n12. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) test, another acquired or congenital immunodeficiency disorder, a history of organ transplantation, or a history of allogeneic bone marrow transplantation.\n13. Poorly controlled cardiac symptoms or disease, including but not limited to:\n\n    * New York Heart Association (NYHA) class II or higher heart failure;\n    * Unstable angina;\n    * Myocardial infarction within the previous year;\n    * Clinically significant supraventricular or ventricular arrhythmia that has not received appropriate clinical intervention or remains poorly controlled after clinical intervention.\n14. A serious infection of greater than Grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) within 4 weeks before the first administration of study treatment, including severe pneumonia requiring hospitalization, bacteremia, or other serious infectious complications; evidence of active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection within 14 days before the first administration of study treatment; or a requirement for oral or intravenous antibiotic treatment within that period. Prophylactic antibiotic use is permitted.\n15. Active tuberculosis identified through medical history or CT examination; a history of active tuberculosis within 1 year before enrollment; or a history of active tuberculosis more than 1 year before enrollment without having received appropriate standard treatment.\n16. Active hepatitis B, defined as hepatitis B virus DNA ≥2,000 IU\u002FmL or ≥10\\^4 copies\u002FmL; or hepatitis C, defined as a positive hepatitis C virus antibody test together with hepatitis C virus RNA above the lower limit of detection of the assay.\n17. Pregnant or breastfeeding female participants.\n18. Any other factor that, in the investigator's judgment, may result in forced premature discontinuation from the study, including another serious illness requiring concomitant treatment, including a psychiatric disorder; alcohol abuse; drug abuse; or family or social circumstances that may affect the participant's safety or compliance.","75 Years",{"count":210,"type":22},92,[25],"This study will evaluate whether two positron emission tomography\u002Fcomputed tomography (PET\u002FCT) scans performed before treatment-68Ga-FAPI and 18F-FDG-can help predict how well patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma respond to immunotherapy plus chemotherapy given before surgery. The study hypothesis is that information from the two scans can identify patients who are unlikely to have a pathologic complete response (pCR), meaning no remaining cancer in the removed esophagus or lymph nodes, and that retlirafusp alfa may improve pathologic response compared with adebrelimab when each is combined with chemotherapy in these patients.\n\nThis study has two stages and plans to enroll 92 adults aged 18 to 75 years with previously untreated, stage II to IVA, resectable thoracic esophageal squamous cell carcinoma. All participants will undergo both PET\u002FCT scans before treatment.",[28,214],"ESCC",[216,214,217,218,219],"PET-CT","Neoadjuvant therapy","Adebrelimab (SHR-1316)","Retlirafusp alfa (SHR-1701)","2026-08-14",{"date":149,"type":37},{"date":34,"type":22},{"date":224,"type":22},"2029-03-01",{"name":226,"class":44},"Tan Lijie",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100632897","phase-1-phase-1-study-of-pf-08046033-in-advanced-solid-tumors-100632897","NCT07519655","Phase 1 Study of PF-08046033 in Advanced Solid Tumors","A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.\n2. Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).\n3. Participants must have measurable disease.\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.\n\nExclusion Criteria:\n\n1. Participants with known clinically active central nervous system (CNS) metastases.\n2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.\n3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.\n4. Untreated clinically significant thromboembolic disease.\n5. Previous exposure to GPNMB-targeted therapy.\n6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.",{"count":235,"type":22},250,[237],"PHASE1","This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.\n\nThe study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.\n\nThe study has two parts:\n\nIn the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.\n\nOnce a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.\n\nParticipants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.",[240,28,241],"Non-Small-Cell Lung","Cutaneous Melanoma",[243,244,89,245],"Lung cancer","Esophageal cancer","Antibody drug conjugate",{"date":194,"type":37},{"date":248,"type":37},"2026-04-08",{"date":250,"type":22},"2029-07-14",{"name":252,"class":120},"Pfizer",15,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":262,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":264,"conditions":265,"keywords":266,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":4},"100651220","ai-driven-digital-twin-and-drug-simulation-for-esophageal-cancer-100651220","NCT07757022","AI-Driven Digital Twin and Drug Simulation for Esophageal Cancer","Construction of Artificial Intelligence Model for Esophageal Cancer Digital Twin Patients and Drug Efficacy Simulation Verification Based on Supercomputing Platform and Multi-Omics Data","ESCA-DT","Inclusion Criteria:\n\n1. Treatment-naïve patients with clinical stage locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma, according to the 8th UICC-TNM staging system.\n2. Cervical color Doppler ultrasound shows no suspicious metastatic lymph nodes, or patients with suspected lymph node metastasis on ultrasound who are eligible for three-field lymphadenectomy.\n3. No prior antitumor therapy for esophageal cancer (including chemotherapy, radiotherapy, or immunotherapy).\n4. Preoperative evaluation of organ function indicates no surgical contraindications.\n5. Adequate bone marrow, liver, and renal function, confirmed by the following laboratory tests performed within 7 days prior to enrollment:\n\n   * Hemoglobin ≥ 90 g\u002FL;\n   * White blood cell count ≥ 4.0 × 10\\^9\u002FL;\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n   * Platelet count ≥ 100 × 10\\^9\u002FL;\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN);\n   * ALT and AST ≤ 2.5 × ULN;\n   * International normalized ratio (INR) of prothrombin time ≤ 1.5 × ULN, with activated partial thromboplastin time (APTT) within normal range;\n   * Serum creatinine ≤ 1.5 × ULN.\n6. No prior chemotherapy, radiotherapy, or hormone therapy for malignant tumors; no history of other malignancies, except for prostate cancer patients who received hormone therapy and have achieved disease-free survival (DFS) \\> 5 years.\n7. Expected to achieve R0 resection.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1.\n9. Life expectancy ≥ 3 months.\n10. Women of childbearing potential must agree to use effective contraceptive measures (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion. Serum or urine pregnancy test must be negative within 7 days prior to enrollment, and patients must not be breastfeeding. Male patients must agree to use contraceptive measures during the study and for 6 months after study completion.\n11. Patients must voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Patients not meeting the inclusion criteria.\n2. Presence of multiple primary malignancies (synchronous or metachronous).\n3. Active infections requiring systemic treatment.\n4. Requirement for continuous systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) for comorbid conditions.\n5. Unstable angina within 3 months or myocardial infarction within 6 months prior to enrollment.\n6. Psychiatric disorders that may affect study compliance.\n7. Known or concurrent hemorrhagic disorders.\n8. Female patients who are pregnant or breastfeeding.\n9. Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or other severe pulmonary impairment.\n10. Autoimmune diseases, immunodeficiency states, or history of organ transplantation.\n11. Known hypersensitivity to the study drugs (toripalimab, paclitaxel, cisplatin) or their excipients.\n12. Abnormal coagulation function (PT \\> 16s, APTT \\> 53s, TT \\> 21s, Fib \\\u003C 1.5 g\u002FL), bleeding tendency, or patients receiving thrombolytic or anticoagulant therapy.\n13. Bronchial asthma requiring intermittent use of bronchodilators or medical intervention.\n14. Active hepatitis B (HBV) or hepatitis C (HCV) infection. (Patients who are HBsAg positive or HBcAb positive may be eligible if HBV DNA is below the lower limit of detection\u002Fquantification; patients who are HCV antibody positive may be eligible if HCV RNA is below the lower limit of detection\u002Fquantification.)\n15. Human immunodeficiency virus (HIV) positivity.\n16. Any other condition that, in the investigator's judgment, may compromise patient safety, interfere with study compliance, or preclude successful completion of the study.",{"count":263,"type":22},400,"This study aims to integrate multi-omics data (genomics, transcriptomics, proteomics) from esophageal cancer patients with artificial intelligence and digital twin technology to construct personalized virtual patient models that precisely simulate individual responses to targeted therapies. Through a drug simulation platform, this study will rapidly screen potential effective drug combinations and optimize dosage and treatment regimens. The project attempts to replace portions of traditional clinical trials with virtual clinical trial technology, substantially shortening the R\\&D cycle, reducing costs, and effectively addressing the complexity of individualized treatment. Specifically, this study will conduct a head-to-head virtual clinical trial parallel to a real-world investigator-initiated trial (IIT) in patients with locally advanced esophageal squamous cell carcinoma, comparing the efficacy predictions from the virtual model with actual clinical outcomes. The ultimate goal is to explore the application of large-scale AI models in esophageal cancer targeted therapy, provide personalized treatment recommendations, and advance the implementation of precision medicine in esophageal cancer.",[28],[28,267,268,269,270,271,272],"Computational Medicine","Multi-Omics","Artificial Intelligence","Virtual Clinical Trials","Digital Twin","Toripalimab","2026-08-10",{"date":275,"type":37},"2026-08-11",{"date":277,"type":22},"2026-07-30",{"date":279,"type":22},"2028-12",{"name":281,"class":282},"Henan Cancer Hospital","OTHER_GOV",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100610406","phase-1-a-study-of-stro-004-in-adults-with-refractoryrecurrent-metastatic-cancer-100610406","NCT07227168","A Study of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Cancer","A Phase 1 Open-Label Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of STRO-004 in Adults With Refractory\u002FRecurrent Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or locally advanced solid tumors including: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Esophageal\u002FGastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Cervical Cancer, Endometrial Cancer, and Urothelial Carcinoma\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1\n* Received all appropriate systemic therapies that are locally available for which they are eligible. For Parts 1A and 1C, there is no limit on the number of prior therapies. For Part 1B only, up to 3 prior therapies are allowed, except for NSCLC participants with genomic alterations, who may have up to 4 prior therapies\n* Availability of tumor tissue\n* Measurable disease per RECIST 1.1\n* Adequate organ function\n* Participants receiving anticoagulants must be on a stable dose\n\nExclusion Criteria:\n\n* Eye disorders\n* Untreated brain metastases\n* Pre-existing clinically significant ocular disorders, active interstitial lung disease, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n* Previous solid organ or bone marrow transplantation\n* Concurrent participation in another therapeutic treatment trial",{"count":131,"type":22},[237],"This is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts:\n\n* Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF).\n* Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity.\n* Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.",[294,295,28,91,138,296,93,94,297],"Head and Neck Squamous Cell Carcinoma HNSCC","Non-Small Cell Lung Cancer NSCLC","Pancreatic Ductal Adenocarcinoma (PDAC)","Urothelial Cancer",[299,300,301,302],"Tissue Factor (TF)","STRO-004","Antibody Drug Conjugate","ADC","2026-08-04",{"date":305,"type":37},"2026-08-06",{"date":307,"type":37},"2025-11-07",{"date":309,"type":22},"2028-04",{"name":311,"class":120},"Sutro Biopharma, Inc.",9,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":23,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100597545","distance-based-exercise-to-preserve-function-and-prevent-disability-100597545","NCT07059884","Distance-Based Exercise to Preserve Function and Prevent Disability","DEFEND","Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon\u002Frectum, endometrium, esophagus, gallbladder, head\u002Fneck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-",{"count":321,"type":22},104,[56],"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.",[325,326,327,100,93,328,94,28,329,91,330,331,99,90,332,333,97,334,335],"Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Colon Cancer","Gall Bladder Cancer","Kidney Cancer","Liver Cancer","Ovarian Cancer","Pancreatic Cancer","Rectal Cancer","Sarcoma",{"date":337,"type":37},"2026-08-05",{"date":339,"type":37},"2026-02-11",{"date":341,"type":22},"2027-08-31",{"name":343,"class":44},"Alliance for Clinical Trials in Oncology",18,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":360,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100552196","phase-1-substudy-06c-a-study-of-investigational-agents-with-pembrolizumab-mk-3475-and-chemotherapy-in-participants-with-first-line-locally-advanced-unresectablemetastatic-gastroesophageal-adenocarcinoma-mk-3475-06ckeymaker-u06-100552196","NCT06469944","Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable\u002FMetastatic Gastroesophageal Adenocarcinoma (MK-3475-06C\u002FKEYMAKER-U06)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable\u002FMetastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically and\u002For cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma\n* Is not expected to require tumor resection during the treatment course\n* Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines\n* Core\u002Fexcisional biopsy of a tumor lesion not previously irradiated has been provided\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline\n* Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible\n* Has adequate organ function\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator\u002Fradiology assessment and verified by blinded independent central review (BICR)\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention\n* Has a life expectancy of at least 6 months\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation\u002Frandomization\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has squamous cell or undifferentiated gastroesophageal cancer.\n* Has had previous therapy for locally advanced unresectable or metastatic gastric\u002Fgastroesophageal junction (GEJ)\u002Fesophageal adenocarcinoma\n* Has experienced weight loss \\>20% over 3 months before the first dose of study intervention\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has Grade ≥2 peripheral neuropathy\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention\n* Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment\n* Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents\n* Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and\u002For a topoisomerase I inhibitor-based chemotherapy\n* Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention\n* Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening\n* Has an active infection requiring systemic therapy\n* Has concurrent active hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus \\[HCV\\] Ab positive and detectable HCV ribonucleic acid \\[RNA\\] infection or a known history of hepatitis B and\u002For C infection\n* Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study\n* Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication\n* Has poorly controlled diarrhea\n* Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention\n* Has history of allogeneic tissue\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":353,"type":22},160,[237,25],"This is a phase 1\u002F2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.\n\nThis substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.",[357,358,359,28],"Gastroesophageal Junction","Gastroesophageal Adenocarcinoma","Esophageal Neoplasms",[361,362,363],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":365,"type":37},"2026-08-07",{"date":367,"type":37},"2024-09-20",{"date":369,"type":22},"2029-09-12",{"name":371,"class":120},"Merck Sharp & Dohme LLC",51,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":393,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":411},"100551821","phase-1-a-study-of-ly4052031-in-participants-with-advanced-or-metastatic-urothelial-cancer-or-other-solid-tumors-100551821","NCT06465069","A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","A Phase 1a\u002F1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","NEXUS-01","Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2\u002FB1\u002FB2: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1\u002FC: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2\u002FB1\u002FB2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1\u002FA2\u002FC: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced\u002Fmetastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic\u002Fadvanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and\u002For clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis\u002Finterstitial lung disease\n* History of Grade ≥3 skin toxicity when receiving enfortumab vedotin\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention",{"count":382,"type":22},420,[237],"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.",[386,387,88,388,389,390,28,333,332,93,391,97,392,95],"Metastatic Solid Tumor","Recurrent Solid Tumor","Urinary Bladder Neoplasm","Triple Negative Breast Cancer","Non-small Cell Lung Cancer","Head and Neck Squamous Cell Carcinoma","Renal Pelvis Cancer",[95,394,395,396,397,398,392,399,400,401,402,98,403],"Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Head and Neck Squamous Cell Carcinoma (HNSCC)",{"date":337,"type":37},{"date":406,"type":37},"2024-07-01",{"date":408,"type":22},"2027-05",{"name":410,"class":120},"Eli Lilly and Company",39,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":420,"briefSummary":421,"conditions":422,"keywords":426,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":4},"100650768","phase-1-a-study-of-lg00313112-in-participants-with-advanced-solid-malignancies-harboring-a-tp53-y220c-mutation-100650768","NCT07752875","A Study of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation","A Phase 1\u002F2, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of LG00313112 in Participants With Advanced Solid Malignancies Harboring a TP53 Y220C Mutation","Inclusion Criteria:\n\n1. Males and females aged 18 years or older\n2. Diagnosed locally advanced unresectable or metastatic solid tumor with a TP53 Y220C mutation.\n3. Documented disease progression during or after the most recent line of therapy. In addition, must be refractory to or intolerant of standard of care therapy or have no standard therapy.\n4. Measurable disease per RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Investigational therapy or anti-cancer therapy within 21 days or 5 half-lives prior to the first dose of study drug.\n2. Radiotherapy within 14 days prior to the first dose of study drug.\n3. Known brain metastases (Exception: Brain metastases are permitted if the participant is neurologically stable), leptomeningeal disease or carcinomatous meningitis.\n4. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n5. History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease\n6. Serious infections requiring intravenous antibiotics within 14 days of first dose of study drug.\n7. Active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n8. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease\n9. History of prior organ transplant\n10. Currently receiving strong Cytochrome P4503A (CYP3A4) inhibitors or inducers",{"count":235,"type":22},[237,25],"This is a first-in-human, Phase 1\u002F2, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of LG00313112 in participants with advanced solid malignancies harboring a TP53 Y220C mutation",[332,423,424,138,28,100,94,90,333,425],"Small Cell Lung Cancer","Non Small Cell Lung Cancer","Locally Advanced Unresectable or Metastatic Solid Tumor",[427],"Solid Tumor, TP53 Y220C Mutation","2026-08-03",{"date":365,"type":37},{"date":431,"type":22},"2026-12-01",{"date":433,"type":22},"2033-04-30",{"name":435,"class":120},"LG Chem",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":453,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":466},"100586075","phase-1-idov-immune-for-advanced-solid-tumors-100586075","NCT06910657","IDOV-Immune for Advanced Solid Tumors","A First-in-human, Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Evidence of Antitumor Activity of IDOV-Immune in Adult Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically confirmed advanced solid tumors that have progressed despite standard therapy, or for which no standard therapy exists.\n* ECOG performance status ≤ 1.\n* Measurable disease per RECIST v1.1.\n* Adequate organ and bone marrow function.\n* At least 28 days since major surgery, prior immunotherapy, or radiotherapy (with exceptions for minor procedures).\n* Negative pregnancy test for women of childbearing potential.\n* Agreement to use effective contraception during treatment and for 3 months after.\n* Ability to provide informed consent and comply with study requirements.\n\nKey Exclusion Criteria:\n\n* Prior treatment with an oncolytic virus.\n* Active or recent vaccinia virus infection or smallpox\u002Fmonkeypox vaccination within 10 years.\n* Active uncontrolled infection requiring systemic treatment.\n* History of hepatitis B, hepatitis C, or HIV (unless meeting protocol-specific criteria).\n* Unresolved ≥ Grade 2 toxicities from prior therapies (except hair loss or stable chronic conditions).\n* Active or symptomatic autoimmune disease requiring systemic therapy.\n* Active or untreated CNS metastases (unless stable per protocol).\n* Significant cardiac disease (e.g., NYHA Class III\u002FIV heart failure).\n* Interstitial lung disease or prior pneumonitis requiring steroids.\n* Conditions requiring chronic immunosuppressive therapy.\n* Severe skin disorders or history of pancreatitis.\n* Bleeding disorders or history of recent serious thromboembolic events.\n* Any medical or psychiatric condition that could interfere with study participation.",{"count":444,"type":22},78,[237],"This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.\n\nThe purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.\n\nParticipants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.\n\nThis study is being conducted at multiple sites in the United States and Australia.",[138,333,89,332,91,28,448,449,100,335,95,99,97,450,451,452],"Hepatocellular Carcinoma","Renal Cell Carcinoma","Cervical Cancers","Head and Neck Cancers","Adrenal Gland Tumors",[454,455,456,457,145,458],"Oncolytic Virus Therapy","Advanced Solid Tumors","Metastatic Cancer","Refractory Cancer","Vaccinia Virus",{"date":337,"type":37},{"date":461,"type":37},"2025-08-25",{"date":463,"type":22},"2027-05-31",{"name":465,"class":120},"ViroMissile, Inc.",5,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":312},"100439243","phase-1-ab122-platform-study-100439243","NCT04999761","AB122 Platform Study","Platform Study of AB122 Based Treatments in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;\n* Has adequate organ function as defined by the following criteria:\n\n  • AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN\n  * T-Bil of ≤ 1.5 × ULN\n  * ANC ≥ 1500 \u002Fmm3 (ie, ≥ 1.5 × 109 \u002FL by International System of Units \\[SI\\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \\[G-CSF\\])\n  * Platelet count ≥ 100000 \u002Fmm3 (SI: ≥ 100 × 109 \u002FL) (excluding measurements obtained within 7 days after a transfusion of platelets)\n  * Hemoglobin value of ≥ 9.0 g\u002FdL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood\n* Has a life expectancy of at least 90 days;\n\nCohort A-1 and A-2\n\n* Japanese male and female;\n* Has a histologically or cytologically confirmed diagnosis of solid tumor;\n* Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;\n\nCohort B-1\n\n* Has a histologically or cytologically confirmed diagnosis of PDAC;\n* Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease\n\nCohort B-2\n\n* Has a histologically or cytologically confirmed diagnosis of CRC.\n* Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy\n\nCohort B-3\n\n* Has a histologically or cytologically confirmed non-squamous NSCLC;\n* Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment\n* Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:\n\n  * Received at least 2 doses at the most recent ICI therapy\n  * Radiographic complete response or partial response based on investigator assessment with ICI therapy\n  * Documented radiographic disease progression with above most recently received regimen\n\nCohort C-1\n\n* Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma\n* Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).\n* Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):\n\n  * fluoropyrimidines and platinum\n  * taxane or irinotecan\n  * ramucirumab\n\nCohort C-2 - Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)\n\n* RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \\[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\\].\n* Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:\n\n  * Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody\n  * For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above\n\nCohort D-1\n\n* Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.\n\nCohort D-2\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease.\n\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-3\n\n* Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.\n* No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.\n\n  * Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.\n  * Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-4\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  • The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\n  • Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-5\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\n  * The confirmed status of the HPV in cancers of the mid-pharynx.\n  * Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort D-6\n\n* Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-7\n\n* Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.\n* No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-8\n\n* Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).\n* No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nCohort D-9 - Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).\n\nThe confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.\n\nPatient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.\n\n\\- No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.\n\nTreatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.\n\nCohort E-1\n\n* Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.\n* Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).\n* Has been received 1-4 regimen for advanced or metastatic disease\n* Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:\n\n  * Received at least 2 doses of the ICI therapy\n  * Documented radiographic disease progression with or after ICI therapy\n\nCohort E-2\n\n* Has a histologically or cytologically confirmed advanced or metastatic ASPS\n* Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure\n\nExclusion Criteria:\n\n* Clinically significant history or current evidence of cardiac arrhythmia and\u002For conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;\n* Treatment with any of the following within the specified time frame prior to the day on which study treatment is scheduled to be started:\n\n  * Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);\n  * Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;\n  * Any anticancer therapy within 2 weeks;\n  * Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever shorter;\n* Unresolved toxicity of ≥ Grade 2 attributed to any prior therapies (excluding anemia, peripheral sensory neuropathy, alopecia and skin pigmentation);\n* A serious illness or medical condition(s) including, but not limited to, the following specific medical conditions:\n\n  * Known acute systemic infection;\n  * Known medical history of interstitial lung disease\u002F drug-induced interstitial lung disease\u002F radiation pneumonitis which required steroid treatment\u002F any evidence of clinically active interstitial lung disease;\n  * Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV, Appendix A) within the previous 6 months; if \\> 6 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms;\n  * Known severe chronic kidney disease;\n  * Known positivity of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody in baseline virus test. In addition, the patient who is known negative in HCV ribonucleic acid (RNA) is eligible, even if positive for HCV antibody;\n  * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment, or may interfere with the interpretation of study results, and in the judgment of the investigator or sub-investigator would make the patient inappropriate for entry into this study;\n* Previous or concurrent cancer that is distinct in primary disease or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (stage Ta, Tis and T1), cancers corresponding to intraepithelial or intramucosal neoplasia, or any cancer curatively treated \\> 5 years prior to the day on which study treatment is scheduled to be started;\n* WOCBP or male patients who do not agree to effective birth control during the following period\n\n  1. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n  2. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;\n* Prior treatment with an anti-PD-L1 anti-PD-1, anti-CTLA-4, or other ICI or agonist as monotherapy or in combination (except for cohort B-3, C-1, D-1 tolerability part and E-1).\n* Has received a live vaccine within 30 days prior to study treatment including, but not limited to the following examples: measles, mumps, rubella, varicella-zoster, yellow fever, and BCG. The inoculation with inactivated vaccines for seasonal influenza is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 28 days by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to enrollment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient\\'s participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. (eg, paresis of intestine, intestinal obstruction, unable to receive 5% dextrose in water \\[DW\\] in patients with diabetes mellitus, respiratory failure, renal failure, hepatic failure, cerebrovascular disorder, gastrointestinal ulcers that require transfusion or are hemorrhagic, and wounds\u002Fbone fractures associated with neovascularization during the healing process, accumulation of pleural within 2 weeks prior to enrollment, ascitic, or pericardial fluid requiring drainage)",{"count":475,"type":22},917,[237],"This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.",[479,480,138,390,91,481,28,90,482],"Advanced or Metastatic Solid Tumor","Pancreatic Ductal Adenocarcinoma","Alveolar Soft Part Sarcoma","Biliary Tract Cancer",{"date":337,"type":37},{"date":485,"type":37},"2021-06-01",{"date":487,"type":22},"2027-06",{"name":489,"class":120},"Taiho Pharmaceutical Co., Ltd.",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":506,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100326192","phase-1-a-study-of-bispecific-antibody-mcla-158-in-patients-with-advanced-solid-tumors-100326192","NCT03526835","A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors","Phase 1\u002F2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in Advanced Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.\n* A baseline fresh tumor sample (FFPE) from a metastatic or primary site (if safe\u002Ffeasible).\n* Amenable for biopsy (if safe\u002Ffeasible).\n* Measurable disease as defined by RECIST version 1.1 by radiologic methods.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks, as per investigator.\n* Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).\n* Adequate organ function\n* Expansion cohorts: patients with locally advanced unresectable or metastatic disease for the following indications:\n\nSINGLE AGENT:\n\n* SECOND-\u002FTHIRD-LINE HNSCC PATIENTS (cohort closed to enrolment): patients who have progressed on or after, or are intolerant to, anti-PD-(L)1 therapy and platinum therapy as monotherapy or in combination with other agents and no previous exposure to EGFR inhibitors. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease should have disease progression within 6 months of the last dose of platinum containing therapy. Patients with no more than 2 prior lines of treatment in recurrent or metastatic disease. • Human papilloma virus (HPV) status determined by p16 immunohistochemistry (IHC) or molecular HPV test for all oropharyngeal tumors should be reported when available.\n* The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.\n* 3L+ mCRC (cohort open to enrolment) patients must have:\n* No oncogenic missense mutations in KRAS, NRAS, BRAF, or EGFR ectodomain, and no HER2 (ERBB2) or KRAS amplification, as detected in plasma by ctDNA NGS central testing performed during screening.\n* A microsatellite stable (MSS) tumor.\n* Received ≥2 and no more than 4 lines of prior therapy in the metastatic setting including:\n\n  1. Chemotherapy with oxaliplatin, irinotecan, and a fluoropyrimidine,\n  2. Targeted therapy with an anti-VEGF therapy\n\nCOMBINATION:\n\n* FIRST-LINE HNSCC (cohort closed to enrolment): patients eligible to receive pembrolizumab as first-line monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1), combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA) approved test in the US, or by an approved equivalent test in other countries; patients should not have previous systemic therapy administered in the recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if ended ≥6 months prior to signing the ICF. The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed.\n* mCRC (cohorts open to enrolment): Patients should have been previously diagnosed with histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Patients must be RAS\u002F RAF WT as determined using tumor tissue (primary or metastatic) by an appropriate tumor tissue based assay, to be confirmed by the sponsor, and must have an MSS tumor. Patients must be naive to prior anti-EGFR therapy.\n\n  i. Cohort to be treated with petosemtamab and FOLFIRI: patients may have received up to 1 prior chemotherapy regimen for the metastatic setting, consisting of 1L fluoropyrimidine-oxaliplatin-based chemotherapy ± bevacizumab.\n\nii. Cohort to be treated with petosemtamab and FOLFOX: patients may have received up to 1 prior chemotherapy regimen in the metastatic setting consisting of 1L fluoropyrimidine-irinotecan-based chemotherapy ± bevacizumab\n\nExclusion Criteria:\n\n* Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days of study entry.\n* Known leptomeningeal involvement.\n* Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.\n* Any systemic anticancer therapy within 4 weeks or 5 half-lives whichever is shorter of the first dose of study treatment. For cytotoxic agents that have major delayed toxicity ( e.g. mitomycin C,nitrosoureas), or anticancer immunotherapies, a washout period of 6 weeks is required.\n* Requirement for immunosuppressive medication (e.g. methotrexate, cyclophosphamide)\n* Major surgery or radiotherapy within 3 weeks of the first dose of study treatment. Patients who received prior radiotherapy to ≥25% of bone marrow are not eligible, irrespective of when it was received.\n* Persistent grade \\>1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v4.03 is allowed.\n* History of hypersensitivity reaction to any of the excipients of petosemtamab, human proteins or any non-IMP treatment required for this study.\n* Uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg) with appropriate treatment or unstable angina. History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia). History of myocardial infarction within 6 months of study entry.\n* History of prior malignancies with the exception of excised cervical intraepithelial neoplasia or nonmelanoma skin cancer, or curatively treated cancer deemed at low risk for recurrence with no evidence of disease for 3 years.\n* Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy. Patients with a history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest computerized tomography (CT) scan.\n* Current serious illness or medical conditions including, but not limited to uncontrolled active infection,clinically significant pulmonary, metabolic or psychiatric disorders.\n* Patients with known infectious diseases:\n\n  i. Active hepatitis B infection (hepatitis B surface antigen \\[HBsAg\\] positive) without receiving antiviral treatment.\n\nii. Positive test for hepatitis C ribonucleic acid (HCV) RNA).\n\n• Pregnant or breastfeeding patients; patients of childbearing potential must use highly effective contraception methods prior to study entry, for the duration of study participation, and for 6 months after the last dose of MCLA-158.",{"count":498,"type":22},560,[237,25],"This is a Phase 1\u002F2 open-label, multi-center, multi-national study with an initial dose escalation part to determine the recommended Phase II dose (RP2D) of MCLA-158 single agent in patients with mCRC.\n\nThe dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study. Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer (mCRC).\n\nThe study will further assess the safety, tolerability, PK, PD, immunogenicity, and anti-tumor activity of MCLA-158 in monotherapy or in combination with other therapies.",[502,138,91,503,504,505,391,28],"Advanced\u002FMetastatic Solid Tumors","Gastroesophageal-junction Cancer","NSCLC","HNSCC",[507,508,509,510,511,512,513,514,515],"Bispecific antibody","First-in-human","MCLA-158","Antibodies","Bispecific","immunologic factors","Cytokines","EGFR","LGR5","2026-07-28",{"date":518,"type":37},"2026-07-29",{"date":520,"type":37},"2018-05-02",{"date":522,"type":22},"2028-11",{"name":524,"class":120},"Merus B.V.",54,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":539,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":45},"100585785","phase-2-pulso-trial-pulsed-low-dose-rate-pldr-radiation-chemoradiation-crt-vs-standard-crt-for-esophageal-cancer-100585785","NCT06906887","PULSO Trial: Pulsed Low-Dose-Rate (PLDR) Radiation Chemoradiation (CRT) vs. Standard CRT for Esophageal Cancer","Inclusion Criteria:\n\nA potential study subject who meets all of the following inclusion criteria is eligible to participate in the study.\n\n1. Age ≥ 18 years.\n2. Stage II-IVb adenocarcinoma of the esophagus (if IVb, oligometastatic only, felt to be eligible for definitive dose CRT treatment by treating physician).\n3. Currently receiving or have received induction chemotherapy and planned for definitive dose chemoradiation (+\u002F- esophagectomy).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n5. Adequate hematologic function within 30 days prior to registration defined as follows:\n\n   1. Absolute Neutrophil Count ≥ 1,500\u002Fmcg\n   2. Hemoglobin ≥ 8 gm\u002FdL\n   3. Platelets ≥ 100,000\u002FmcL.\n6. Adequate renal function within 30 days prior to registration, defined as a creatinine clearance of ≥ 50 ml\u002Fmin as calculated by the Cockcroft-Gault equation.\n7. Adequate hepatic function within 30 days prior to registration, defined as total bilirubin ≤ 1.5 x ULN\n\n   a. Note: patients with known Gilbert Syndrome can have a total bilirubin \\\u003C 2.5 x upper limit of normal (ULN).\n8. Female patients \\\u003C65 years of age and of childbearing potential must have a negative serum\u002Furine pregnancy test within 14 days prior to study entry. A female not of childbearing potential is one who has undergone a hysterectomy, bilateral oophorectomy, tubal ligation, or who has had no menses for 12 consecutive months.\n9. Patients of reproductive potential must agree to use effective contraception for the duration of study treatment. Effective contraception includes oral contraceptives, implantable hormonal contraception, double-barrier method, or intrauterine device.\n10. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n11. Ability to understand a written informed consent document, and the willingness to sign it.\n\nExclusion Criteria:\n\nA potential study subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Age \\\u003C 18 years.\n2. Extensive distant metastatic cancer, defined as \\>5 metastases.\n3. Recurrent esophageal cancer.\n\n   a. Note: prior or concurrent malignancies are allowed if they do not impact the study's primary endpoint (i.e., treatment-associated toxicity).\n4. Prior non-approved chemotherapy for the treatment of cancer.\n5. Prior radiotherapy to the region of the study cancer that would result in an overlap of radiation therapy fields.\n6. Women must not be pregnant or breast-feeding.",{"count":533,"type":22},50,[25],"This is a prospective, randomized, open-label, two-arm phase 2 trial that will evaluate whether the use of Pulsed Low-Dose-Rate radiation technique, as compared to standard radiation, is associated with reduced rates of clinically significant esophagitis during and following chemoradiation.",[28,537,538],"Oesophageal Cancer","GastroEsophageal Cancer",[540,541,542,543,28,537,538,544,545],"Pulsed Low-Dose-Rate Radiation","Chemoradiation","esophagitis","Esophagectomy","Pulsed reduced dose rate radiation","Pulsed radiation","2026-07-27",{"date":516,"type":37},{"date":549,"type":37},"2025-06-17",{"date":551,"type":22},"2032-06-01",{"name":553,"class":44},"Medical College of Wisconsin",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":561,"targetDuration":4,"studyType":23,"phases":563,"briefSummary":564,"conditions":565,"keywords":566,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":577},"100649343","phase-2-comparing-ici-followed-by-ccrt-and-ccrt-followed-by-immunotherapy-in-unresectable-la-escc-100649343","NCT07733830","Comparing ICI Followed By CCRT And CCRT Followed By Immunotherapy In Unresectable LA-ESCC","Comparing Induced Chemoimmunotherapy Followed By Concurrent Chemoradiotherapy And Concurrent Chemoradiotherapy Followed By Immunotherapy In Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Randomized, Phase II Trial","Inclusion Criteria:\n\n1. Volunteered to participate, cooperated with follow-up visits, documented informed consent;\n2. Aged 18 -75 years, both male and female;\n3. Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC); clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery);\n4. Measurable and\u002For unmeasurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST1.1) and the Japanese Classification of Esophageal Cancer (12th Edition: Part II);\n5. Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);\n6. ECOG performance status 0 or 1;\n7. Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \\[FFPE\\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;\n8. Expected survival ≥ 3 months;\n9. Adequate hematologic function, defined as ANC ≥1500\u002Fμl, platelet count ≥100,000\u002Fμl and hemoglobin count ≥9.0 g\u002Fdl or ≥5.6 mmol\u002Fl; Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL\u002Fmin for those with creatinine levels \\>1.5× ULN (Calculated from the Cockcroft-Gault formula); Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT\u002FAST\u002FAKP levels ≤2.5× ULN and albumin ≥2.8 g\u002Fdl; Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;\n10. Women of childbearing potential with a negative urine pregnancy test within 3 days before the first administration of the investigational drugs.\n\nExclusion Criteria:\n\n1. Surgery for esophageal cancer;\n2. Esophageal fistulae due to infiltration of the primary tumour;\n3. Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation\n4. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;\n5. Major surgery or severe trauma within 4 weeks prior to first use of study drug;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n7. Received or receiving any of the following treatments in the past:\n\n   1. Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;\n   2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;\n   3. Systemic treatment with corticosteroids (\\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the oesophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor.Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \\>10mg\u002Fday prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;\n   4. Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;\n8. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;\n9. Diagnosis of immunodeficiency, including positive HIV test,other acquired\u002Fcongenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;\n10. Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n11. Severe infections (CTCAE \\> Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;\n12. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;\n13. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;\n14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);\n15. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than Grade 1 within 2 weeks prior to randomisation that do not improve with treatment;\n16. Known hypersensitivity to large protein preparations, or to any of the components of nab-paclitaxel or carboplatin or to any of the components used within their preparations;\n17. Any other malignant tumor was diagnosed before the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate \\> 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;\n18. Pregnant or lactating patients;\n19. After the researchers' judgment, the subjects have other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, having other serious diseases recently (such as myocardial infarction, cerebrovascular accident) that are considered to have a high risk of recurrence, severely abnormal laboratory test values, family or social factors. Situations that may affect the safety of the subjects or the collection of experimental data.",{"count":562,"type":22},120,[25],"A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups.\n\nArm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy\u002F1.8Gy\u002F28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles.\n\nArm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy\u002F1.8Gy\u002F28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles.\n\nThis study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.",[28],[567,31,568],"Induction Immunochemotherapy","Esophageal Squamous Cell Carcinoma","2026-07-26",{"date":518,"type":37},{"date":572,"type":22},"2026-07-31",{"date":574,"type":22},"2029-12-31",{"name":576,"class":44},"Tianjin Medical University Cancer Institute and Hospital",7,{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":600},"100550353","phase-1-substudy-06d-combination-therapies-in-second-line-2l-gastroesophageal-adenocarcinoma-mk-3475-06dkeymaker-u06-100550353","NCT06445972","Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D\u002FKeymaker-U06)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced\u002FMetastatic Gastroesophageal Adenocarcinoma: Substudy 06D","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically and\u002For cytologically confirmed diagnosis of previously treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma\n* Has metastatic disease or locally advanced, unresectable disease\n* Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum\u002Ffluoropyrimidine doublet with or without immunotherapy\n* Tumor tissue must be confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines\n* Can provide a core\u002Fexcisional biopsy of a tumor lesion not previously irradiated (collected from a biopsy performed after the most recent systemic anticancer therapy regimen)\n* AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable\n* Has Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has a life expectancy of at least 3 months\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation\u002Frandomization\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has squamous cell or undifferentiated gastroesophageal cancer\n* Has experienced weight loss \\>20% over 3 months before the first dose of study intervention\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has Grade ≥2 peripheral neuropathy\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to allocation\u002Frandomization\n* Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to allocation\u002Frandomization\n* Has uncontrolled arterial hypertension ≥150\u002F≥90 mm mercury (Hg)\n* Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment\n* Has undergone major surgery within 28 days prior to allocation\u002Frandomization, or central venous access device placement within 7 days prior to allocation\u002Frandomization or planned major surgery following initiation of study treatment\n* Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents\n* Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents\n* Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to allocation\u002Frandomization\n* Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry\n* Has history of GI perforation and\u002For fistulae within 6 months prior to allocation\u002Frandomization\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)- or HER3-targeted agent, topoisomerase 1 inhibitor-based ADC and\u002For a topoisomerase 1 inhibitor-based chemotherapy, or any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or the vascular endothelial growth factor receptor (VEGFR) signaling pathways\n* Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Has concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid) infection\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease, or where suspected ILD or pneumonitis cannot be ruled out by imaging at screening\n* Has severe hypersensitivity (Grade ≥3) to MK-2870, or HER3-DXd, any of their excipients, and\u002For to another biologic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications",{"count":586,"type":22},210,[237,25],"This is a phase 1\u002F2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.",[357,358,359,28],[591,362,363],"Programmed Cell Death 1 (PD1, PD-1)","2026-07-22",{"date":594,"type":37},"2026-07-24",{"date":596,"type":37},"2024-08-07",{"date":598,"type":22},"2030-08-08",{"name":371,"class":120},47,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":344},"100602476","destiny-pantumour04-100602476","NCT07124000","DESTINY-PANTUMOUR04","Effectiveness of T-DXd Across HER2-positive Solid Tumors in Patients Who Have Received Prior Systemic Treatment and Have no Satisfactory Alternative Treatment Options: A Hybrid Observational Study","DP-04","Inclusion Criteria:\n\n1. Adults aged ≥18 years\n2. Patients with locally advanced, unresectable, or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options as determined by the Investigator (see Exclusion Criterion 1 for excluded solid tumors);\n3. A clinician decision has been made for treatment with T-DXd in accordance with the FDA label;\n4. HER2-positive (IHC 3+) by local testing prior to study enrolment at the time of signed and dated informed consent;\n5. Patients who are willing and able to provide a signed and dated informed consent.\n\nExclusion Criteria:\n\n1. Primary diagnosis of adenocarcinoma of the breast, adenocarcinoma of the colon or rectum, NSCLC, adenocarcinoma of the gastric body or gastroesophageal junction or hematological malignancies;\n2. Prior T-DXd therapy;\n3. Patients without a baseline assessment of tumor burden undertaken prior to initiating T-DXd.\n4. Patient is participating in a clinical trial at time of enrolment","130 Years",{"count":611,"type":22},100,"This study will evaluate the effectiveness of T-DXd in patients with HER2-positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have received prior systemic treatment for metastatic or advanced disease and have no satisfactory alternative treatment options in a real-world setting in the US",[614,326,95,93,94,28,329,615,90,331,89,616,617,618,332,333,97,449,619,335,423,620,621,622,623,624,625],"Adenocarcinoma (NOS)","Gastrointestinal Stromal Tumour","Mouth Cancer","Nasopharangeal Cancer","Neuroendocrine, Gastrointestinal Cancer","Salivary Gland Cancer","Testicular Cancer","Throat Cancer","Thyroid Cancer","Urethral Cancer","Vaginal Cancer","Vulvar Cancer","2026-07-21",{"date":592,"type":37},{"date":629,"type":37},"2025-09-18",{"date":631,"type":22},"2028-03-30",{"name":633,"class":120},"AstraZeneca",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":23,"phases":643,"briefSummary":644,"conditions":645,"keywords":652,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":673,"startDateStruct":674,"completionDateStruct":676,"leadSponsor":678,"locationsCount":679},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":642,"type":22},310,[237],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[502,95,646,647,648,649,90,28,650,568,190,651,333],"Urothelial Carcinoma","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Gastroesophageal Junction Adenocarcinoma","Pancreatic Adenocarcinoma",[653,654,302,655,656,657,658,504,659,505,660,661,662,663,664,665,666,667,668,669,670,671,672],"B6C","integrin beta 6","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","head and neck cancer","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6",{"date":592,"type":37},{"date":675,"type":37},"2025-08-20",{"date":677,"type":22},"2029-07-08",{"name":252,"class":120},30,{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":4,"eligibilityCriteria":686,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":687,"targetDuration":4,"studyType":23,"phases":689,"briefSummary":690,"conditions":691,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":694,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":312},"100356134","phase-1-apg-2449-in-patients-with-advanced-solid-tumors-100356134","NCT03917043","APG-2449 in Patients With Advanced Solid Tumors","A Phase I Study of the Safety, Pharmacokinetic and Pharmacodynamic Properties of Orally Administered APG-2449 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Dose exploration stage: non-small cell lung cancer diagnosed by histology and\u002For cytology and positive for ALK\u002FROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, esophageal cancer and ovarian cancer. Kind of patients with advanced tumors.\n\n   Expansion stage: cohort 1, patients with non-small cell lung cancer who have progressed or are intolerant to TKI therapy, including patients with second-generation ALK TKI, or either ROS1 TKI, or third-generation ALK inhibitor (lorlatinib, etc.) with pFAK expression (pFAK expression is subject to central laboratory results) of about 10 or above; Cohort 2, TKI-naïve patients with ALK\u002FROS1 fusion gene positive NSCLC. The molecular diagnosis results of the above patients can be confirmed by the investigator.\n2. ECOG Performance Status ≤ 1.\n3. Expectation of life ≥ 3 months.\n4. According to RECIST version 1.1, there is at least 1 measurable lesion.\n5. Adequate hematologic and bone marrow functions.\n6. Adequate renal and liver function.\n7. Normal cardiac function.\n8. Brain metastases with clinically controlled neurologic symptoms.\n9. Serum pregnancy test results of women of childbearing age were negative within 7 days before taking the first dose of study drug.\n10. Men, women of childbearing age (postmenopausal women must have been menopausal for at least 12 months before they can be considered infertile) and their partners voluntarily take the study drug for at least 30 days after signing the informed consent form and taking the study drug as deemed effective by the investigator Contraceptive measures\n11. Ability to understand and willingness to sign a written informed consent form\n12. Subjects must be willing and able to complete the research procedures and follow-up inspections.\n13. Subjects are required to provide fresh (for recurrent subjects only) or archived tumor tissue samples from within 28 days prior to treatment. If none of these specimens are available, they may be included after consultation with the sponsor.\n14. Subjects should provide fresh biopsy tumor tissue specimens prior to treatment.\n\nExclusion Criteria:\n\n1. Receiving concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy); or any investigational therapy within 28 days prior to the first dose of study drug.\n2. Receiving TKI therapy within 8 days prior to the first dose of study drug.\n3. Continuance of toxicities due to prior therapy that do not recover (CTCAE V5.0 Grade\\> 1).\n4. Has difficulty in swallowing, absorbing barrier, or other diseases blocking APG-2449' taken.\n5. Obvious cardiovascular disease history.\n6. Failure to recover adequately, as judged by the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.\n7. Active symptomatic fungal, bacterial and\u002For viral infection including, but not limited to, active human immunodeficiency virus (HIV) or viral hepatitis (B or C).\n8. Known allergies to study drug ingredients or their analogs.\n9. Female subjects who are pregnant or breastfeeding, or expecting to become pregnant during the study period.\n10. According to the judgment of the investigator or sponsor, any symptoms or disease of the subject may endanger its safety or interfere with the safety assessment of the study drug.\n11. Subjects who have used CYP3A4, CYP2C9, or CYP2C19 moderately potent inhibitors or moderately potent inducers 1 week before receiving the study drug for the first time.\n12. Subjects who used CYP3A4 substrates and narrow treatment window 1 week before the first study drug.",{"count":688,"type":22},165,[237],"APG-2449 is a novel, orally active, multi-targeted tyrosine kinase inhibitor, which inhibits FAK, ALK, and ROS1 with nanomolar potencies. In preclinical studies, APG-2449 demonstrated potent antiproliferative activity in various cancer cell lines as a single agent. In combination treatment, APG-2449 enhanced anti-proliferative activities of several chemotherapeutic and targeted agents. It is indicated that APG-2449 may have a broad therapeutic potential for the treatment of human cancer as a single agent and in combination with other classes of anticancer drugs. APG-2449 is intended for the treatment of patients with advanced solid tumors. Upon completion of the Phase 1 dose escalation study to establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and\u002For recommended phase 2 dose (RP2D), several phase Ib\u002FII studies will be implemented accordingly.",[692,424,28,332,693],"Advanced Solid Cancer","Malignant Pleural Mesothelioma",{"date":695,"type":37},"2026-07-23",{"date":697,"type":37},"2019-05-27",{"date":699,"type":22},"2028-01",{"name":701,"class":120},"Ascentage Pharma Group Inc.",{"id":703,"slug":704,"hasResults":12,"nctId":705,"briefTitle":706,"officialTitle":706,"acronym":4,"eligibilityCriteria":707,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":708,"targetDuration":4,"studyType":133,"phases":4,"briefSummary":710,"conditions":711,"keywords":712,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":717,"lastUpdatePostDateStruct":718,"startDateStruct":719,"completionDateStruct":721,"leadSponsor":723,"locationsCount":725},"100452890","treatment-outcomes-of-esophageal-cancer-100452890","NCT05177393","Treatment Outcomes of Esophageal Cancer","Inclusion Criteria:\n\n* Participants with histopathologically confirmed or presumptive clinical diagnosis of EC. For patients who do not have histopathologically confirmed disease, presumptive clinical diagnosis may be based upon barium swallow or endoscopy without biopsy.\n* Age 18 years of age or older;\n\nExclusion Criteria:\n\n* Unable to provide informed consent",{"count":709,"type":22},2476,"This study will be a carried out through a prospective observational cohort design in conjunction with researchers in the African Esophageal Cancer Consortium (AfrECC). The purpose of this research is to prospectively evaluate outcomes related to existing treatment strategies for esophageal cancer (EC) at participating sites within AfrECC.",[28],[713,714,715,716],"Treatment outcomes","Quality of life","Comparative effectiveness","Palliation","2026-07-20",{"date":592,"type":37},{"date":720,"type":37},"2019-02-28",{"date":722,"type":22},"2027-06-30",{"name":724,"class":44},"University of California, San Francisco",6,{"id":727,"slug":728,"hasResults":12,"nctId":729,"briefTitle":730,"officialTitle":731,"acronym":4,"eligibilityCriteria":732,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":733,"targetDuration":4,"studyType":23,"phases":735,"briefSummary":736,"conditions":737,"keywords":738,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":740,"lastUpdatePostDateStruct":741,"startDateStruct":742,"completionDateStruct":744,"leadSponsor":746,"locationsCount":748},"100538673","phase-1-open-label-study-to-evaluate-bl-m07d1-in-her2-expressing-malignant-solid-tumors-100538673","NCT06293898","Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors","A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors","Inclusion Criteria:\n\nParticipants must meet all the following inclusion criteria to be eligible for participation in this study:\n\n1. Signed the informed consent form voluntarily and agreed to follow the program requirements.\n2. Either sex\n3. Age: ≥18 years\n4. Life expectancy of ≥3 months\n5. For Dose Escalation and Dose Finding: Documented locally advanced or metastatic HER2-expressing (IHC 1+ to 3+ and\u002For HER2 gene amplification or activating mutation \\[see Table 17-5\\] in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:\n\n   1. Cohort 1: Participants with HER2 expression in endometrial cancers\n   2. Cohort 2: Participants with HER2 expression in cervical cancers\n   3. Cohort 3: Participants with HER2 expression in ovarian cancers, including fallopian tube cancer and primary peritoneal cancer\n   4. Cohort 4: Participants with HER2 expression in urothelial cancers\n   5. Cohort 5: Participants with HER2 expression in biliary tract cancers\n   6. Cohort 6: Participants with HER2 expression in breast cancer\n   7. Cohort 7: Participants with HER2 expression in lung cancer\n   8. Cohort 8: Participants with HER2 expression in gastric, esophageal, or gastroesophageal junction (GEJ) cancers\n   9. Cohort 9: Participants with HER2 expression in other solid tumors as approved by the medical monitor Note: For indications in which a HER2-directed therapy is approved, the approved treatment is recommended although not mandated, at the discretion of the investigator.\n6. Agree to provide most recent existing tumor samples (formalin-fixed paraffin-embedded \\[FFPE\\] tissue block or slides) from primary or metastatic sites for tissue-based IHC staining to centrally determine HER2 expression (see details in Section 7.1.1).\n\n   1. In dose escalation and dose finding: archival tissue or fresh biopsy. If no archival tissue is available or it is not possible to obtain a fresh tissue biopsy, medical monitor approval is required to screen participant;\n   2. In dose expansion: an FFPE block or slides from fresh biopsy or the most recent archival tissue is required.\n7. At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) V1.1\n8. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1\n9. Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by the National Cancer Institute (NCI) CTCAE V5.0, except for alopecia and endocrinopathies controlled by replacement therapy that must be Grade ≤2\n10. No serious cardiac dysfunction, left ventricular ejection fraction ≥50%\n11. Adequate organ function before enrollment, defined as:\n\n    1. Marrow function: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet (PLT) count ≥100×10\\^9\n\n       \u002FL, hemoglobin (Hb) ≥9.0 g\u002FdL \\[blood transfusion, PLT transfusion, erythropoietin, hematopoiesis agents, and granulocyte colony-stimulating factor (G-CSF) use are not allowed 1 week prior to screening\\]\n    2. Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (≤3×ULN for participants with Gilbert's syndrome or liver metastasis at baseline), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) without liver metastasis ≤3.0×ULN, AST and ALT with liver metastasis ≤5.0×ULN\n    3. Renal function:\n\n       1. In dose escalation and dose finding: Creatinine (Cr) clearance ≥50 mL\u002Fminute (Cockcroft-Gault equation) or estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73 m\\^2 (Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n       2. In dose expansion: Cr clearance ≥40 mL\u002Fminute (Cockcroft-Gault equation) or eGFR ≥40 mL\u002Fmin\u002F1.73 m\\^2 (CKD-EPI equation)\n12. Coagulation parameters: International Normalized Ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, unless receiving anticoagulation therapy with prothrombin time and aPTT levels within the intended therapeutic range\n13. Urine protein ≤2+ or ≤1000 mg\u002F24 hours (in dose escalation and dose finding only)\n14. Sexually active fertile participants and their partners must agree to use highly effective methods of contraception (defined in Appendix D) during the course of the study and for a washout period after the last dose of study treatment (7 months for women of childbearing potential and 4 months for men). An additional contraceptive method, such as a barrier method (eg, condom), is recommended.\n15. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and must be nonlactating. Female participants are considered WOCBP unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\>45 years old in the absence of other biological or physiological causes). In addition, females \\\u003C55 years old must have a serum follicle stimulating hormone (FSH) level \\>40 mIU\u002FmL to confirm menopause. NOTE: Documentation may include review of medical records, medical examination, or medical history interview by study site staff. Additional Inclusion Criteria for Dose Expansion\n16. For participants with urothelial carcinoma (Part A: Randomized Doses):\n\n    1. Histologically confirmed advanced or unresectable HER2-expressing (as defined in Inclusion Criterion #5) urothelial carcinoma of the upper or lower urinary tract, not amenable to curative surgery or radiation. Mixed histological types are allowed if urothelial is the primary histology; however, small cell histology is excluded.\n    2. Participants with progression or recurrence following receipt of an ADC (eg, enfortumab vedotin or disitamab vedotin) and anti-PD1\u002FPD-L1 therapy (either as a combination regimen or as separate lines of therapy) in the advanced or metastatic setting. Patients treated with enfortumab\u002Fpembrolizumab in the localized muscle invasive setting will be eligible. Prior platinum therapy is allowed but not required.\n\n    Participants should have no more than 3 prior lines of systemic cytotoxic therapy (eg, ADC, chemotherapy) in the advanced or metastatic setting.\n17. Multiple Indications (Part B: Basket Dosing):\n\n    Has documented locally advanced or metastatic HER2-expressing (as defined in Inclusion Criterion #5) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lines of standard therapy, including adjuvant\u002Fneoadjuvant treatment, or whose cancer is considered refractory to the standard of care or for which no standard treatment is available, including:\n    1. Participants with HER2 expression in endometrial cancer\n    2. Participants with HER2 expression in cervical cancer\n    3. Participants with HER2 expression in ovarian cancer, including fallopian tube cancer and primary peritoneal cancer\n    4. Participants with HER2 expression in breast cancer, status post-trastuzumab deruxtecan\n    5. Participants with HER2 expression in breast cancer, trastuzumab deruxtecan-naïve\n    6. Participants with HER2 expression in gastric, esophageal, or GEJ cancers\n18. Participants deemed at high-risk for infection, including those with an indwelling catheter or ostomy, must be willing to receive prophylactic G-CSF during their time on study (see Section 6.3.3.5).\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will not be eligible for participation in this study:\n\n1. Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration\n2. Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA)\n\n   ≥ Grade 2 heart failure at any time, or history of myocardial infarction or unstable angina pectoris within 6 months before enrollment.\n3. Participants with prolonged QT interval corrected Fridericia formula (\\[QTcF\\]\\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block\n4. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc. Participants with skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), well-controlled type 1 diabetes, or hypothyroidism are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening\n5. Participants with other prior malignancies except for: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and\u002For carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years prior to screening\n6. Participants with poorly controlled hypertension by 2 types of antihypertensive drugs (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg)\n7. Participants with advanced or clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease and asthma, restrictive lung disease, pulmonary hypertension, etc.\n8. Participants who have a history of noninfectious interstitial lung disease (ILD)\u002F pneumonitis that required treatment with steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n9. Participants with stroke or transient ischemic attack (TIA) within 6 months before enrollment\n10. Participants with a thromboembolic event (eg, deep vein thrombosis or pulmonary embolism) within 6 months before enrollment except for those who are clinically stable and receiving treatment with adequate anticoagulant therapy for at least 3 weeks before enrollment\n11. Participants with primary tumors in the central nervous system (CNS) and active or untreated CNS metastases and\u002For carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to dosing with the investigational product (IP). Patients on low dose corticosteroids (\\\u003C10 mg prednisone or equivalent\u002Fday) may participate\n12. Participants with pre-existing Grade ≥2 peripheral neuropathy\n13. Participants who have a history of anaphylaxis or severe hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies or any of the components of BL-M07D1\n14. Participants who are receiving treatment with systemic glucocorticoids \\>10 mg\u002Fday equivalent of prednisone, except for the treatment of chronic obstructive pulmonary disease, antiemetic, infusion reactions; however, treatment with low dose glucocorticoids (≤10 mg\u002Fday equivalent of prednisone) is permitted. The chronic use of topical, inhaled, and locally injected steroids is permitted\n15. Participants who have received treatment with anthracyclines with a cumulative dose exceeding 360 mg\u002Fm\\^2\n16. Participants with known human immunodeficiency virus (HIV) infection (HIV antibody positive). Participants who are HIV positive are allowed to participate if all the following criteria are met:\n\n    1. Undetectable HIV RNA and CD4 count ≥ 350 cells\u002FμL at screening;\n    2. No AIDS-defining opportunistic infection within 12 months prior to screening;\n    3. On stable antiretroviral therapy (ART) for at least 4 weeks prior to enrollment with projected continuation of ART as clinically indicated while on the study.\n17. Participants with active hepatitis B virus (HBV) infection (positive HBsAg test).\n\n    Participants with a chronic inactive HBV infection are eligible if all the following criteria are met:\n    1. Have an HBV DNA viral load \\\u003C 500 IU\u002FmL;\n    2. Have normal AST and ALT, OR if liver metastasis is present, have AST and ALT \\\u003C3×ULN which are not attributed to HBV infection;\n    3. Are on antiviral treatment, as clinically indicated.\n18. Participants with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV RNA \\> the lower limit of detection). Participants with a positive anti-HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n19. Participants with known active tuberculosis\n20. Participants with active infections requiring IV antibiotic, antiviral, or antifungal treatment, such as severe pneumonia, bacteremia, sepsis, etc., within 1 week prior to first dose of study treatment. Participants on stable oral antimicrobials with no clinical or laboratory evidence of active infection are eligible\n21. Participants who are pregnant, breastfeeding, or planning to become pregnant during the study\n22. Other conditions that the investigator or sponsor believes are not suitable for participating in this clinical trial.\n23. For Dose Expansion Only: Prior treatment with any topoisomerase inhibitor ADC. If the topoisomerase I ADC is sacituzumab govitecan, prior discussion with the medical monitor is required for potential inclusion",{"count":734,"type":22},280,[237],"The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.",[94,93,332,646,482,100,99,91,503,28],[739],"HER2","2026-07-16",{"date":717,"type":37},{"date":743,"type":37},"2024-02-09",{"date":745,"type":22},"2029-04-15",{"name":747,"class":120},"SystImmune Inc.",17]