[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,257,0,25,[9,49,74,94,115,135,167,199,225,255,282,308,332,353,378,402,432,452,475,495,514,544,573,600,659],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100573082","phase-1-a-phase-iii-study-of-cs2009-in-participants-with-advanced-solid-tumors-100573082",false,"NCT06741644","A Phase I\u002FII Study of CS2009 in Participants With Advanced Solid Tumors","A Phase I\u002FII, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1\u002FVEGFA\u002FCTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Age ≥ 18 years on the day of signing informed consent.\n\nPhase I:\n\n* Pathologically or cytologically confirmed, unresectable advanced solid tumors, including but not limited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), gastric cancer (GC), ovarian cancer (OC), cervical cancer (CC), etc.\n* Failure of established standard of care for advanced disease, or no available standard of care.\n\nPhase II:\n\n* Pathologically or cytologically confirmed unresectable advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), etc.\n* Participants with at least one measurable lesion as defined per RECIST v1.1 solid tumor.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ function.\n* Fertile male participants and female participants of childbearing potential must be willing to use an effective method of birth control from providing signed consent and for 180 days after the last investigational product administration.\n* Female participants of childbearing potential must have a negative pregnancy test ≤ 7 days prior to the first dose of the investigational product.\n\nExclusion Criteria:\n\n* History of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is either symptomatic, untreated, or requires therapy.\n* Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage within 4 weeks prior to the first dose of investigational product.\n* Receipt of systemic corticosteroid treatment or any other form of immune suppressing treatment within 7 days prior to the first dose of investigational product.\n* Active or prior history of definite inflammatory bowel disease.\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or presence of active or suspected ILD\u002Fpneumonitis.\n* Active infections requiring systemic therapy within 2 weeks prior to the first dose of investigational product.\n* Positive for human immunodeficiency virus (HIV) or presence of acquired immune deficiency syndrome (AIDS).\n* Active Hepatitis B or C infection.\n* Active pulmonary tuberculosis (TB).\n* Major surgery, chemotherapy, definitive radiotherapy, target therapy, immunotherapy, or other anti-cancer therapy within 21 days prior to the first dose of investigational product.\n* Palliative radiotherapy within 14 days prior to the first dose of investigational product, or receipt of radioactive drug within 56 days prior to the first dose of investigational product.\n* Administration of live vaccine within 28 days prior to the first dose of investigational product.\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n* Receipt of antitumor Chinese herbal preparations or Chinese patent medicine within 7 days prior to the first dose of investigational product.\n* Receipt of any other investigational drugs within 21 days prior to the first dose in this trial.\n* History of hypersensitivity or idiosyncrasy to the excipients of the study drug or any monoclonal antibody.\n* Any toxic effects of prior therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1.\n* Active alcohol or drug abuse.\n* Female participants who are pregnant or breastfeeding.\n* Other acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or investigational product administration.","ALL","18 Years",{"count":20,"type":21},800,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a first-in-human (FIH), open-label, and multi-center Phase I\u002FII study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.",[28],"Advanced Solid Tumors",[30,31,32,33,34,35],"PD-1","VEGFA","CTLA4","tri-specific antibody","advanced solid tumors","Phase I","RECRUITING","2026-08-19",{"date":39,"type":40},"2026-08-20","ACTUAL",{"date":42,"type":40},"2025-02-24",{"date":44,"type":21},"2028-01",{"name":46,"class":47},"CStone Pharmaceuticals","INDUSTRY",33,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100652903","phase-1-a-phase-1-open-label-dose-escalation-study-to-evaluate-safety-tolerability-and-clinical-activity-of-cbx-663-in-participants-with-relapsed-or-refractory-myeloid-malignancies-advanced-solid-tumors-or-recurrent-or-progressive-glioblastoma-100652903","NCT07779798","A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety, Tolerability, and Clinical Activity of CBX-663 in Participants With Relapsed or Refractory Myeloid Malignancies, Advanced Solid Tumors, or Recurrent or Progressive Glioblastoma.","TelOscope","Inclusion Criteria:\n\nCohort A (R\u002FR AML, MDS or CMML) Specific Inclusion Criteria:\n\n1. R\u002FR AML, as defined by standardized criteria (e.g., European Leukemia Net criteria (Dohner, 2022) (Arber, 2022); after standard of care therapy. Participants with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including HSCT) are eligible. Participants must have bone marrow blasts ≥5%.\n2. R\u002FR MDS as per WHO 2022. Participants must have peripheral or bone marrow blasts \\\u003C20%, and must have exhausted locally available treatments, including treatments for actionable mutations.\n\n   a. For High-Risk MDS participants, participants must be resistant to or refractory to at least 4 cycles of hypomethylating agents or have progressed or are intolerant to such agents.\n3. R\u002FR dysplastic or proliferative CMML participants, participants must be resistant or refractory to 4-6 cycles of hypomethylating agents (HMA; decitabine or azacitidine).\n4. White blood cells must be below 25,000\u002FµL at time of enrollment. Participants may receive cytoreduction prior to enrollment.\n5. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia.\n\n   Cohort B (Solid Tumor) Specific Inclusion Criteria:\n6. Histologically or cytologically diagnosed, locally advanced (unresectable) or metastatic solid cancers that have progressed after all available standard therapy for the specific tumor type, or for which no standard therapy exists. Participants for whom standard therapies are intolerable or considered inappropriate by the Investigator are eligible.\n7. Measurable disease (as defined by RECIST version 1.1).\n\n   Prior Therapy\n8. Any prior treatment-related toxicities resolved to Grade ≤1 prior to enrollment, with the exception of Grade ≤2 alopecia.\n9. Steroids: At least 7 days since systemic glucocorticoid therapy, unless receiving physiologic dosing (equivalent to ≤10 mg prednisone daily) or cytoreductive therapy. Cytoreductive therapy must have approval of the Study Responsible Physician.\n10. Hematopoietic Growth Factors: At least 7 days since the completion of therapy with short-acting hematopoietic growth factors and 14 days with long-acting growth factors.\n11. Anti-Cancer Therapy: Chemotherapy or small molecule targeted therapy, either investigational or commercially approved and available, within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study drug administration.\n12. Radiation Therapy: At least 60 days from prior total body irradiation, craniospinal radiation and\u002For ≥50% radiation of the pelvis, or at least 14 days from local palliative radiation therapy (small port).\n\n    Cohort C (Recurrent\u002FProgressive GBM) Specific Inclusion Criteria:\n13. Histologically confirmed or molecularly defined diagnosis of glioblastoma (IDH-wildtype) according to WHO 2021.\n14. Historical documented evidence of a TERT promoter mutation.\n15. Radiographic evidence of recurrent or progressive disease following prior first-line radiotherapy, defined as progression per RANO 2.0 criteria, as determined by investigator assessment. Prior use of tumor-treating fields is allowed but not required (Wen, 2023).\n16. Measurable (at least 1 cm x 1 cm) enhancing tumor.\n17. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia and ≤Grade 2 fatigue.\n\n    Inclusion Criteria for All Participants:\n18. Aged ≥18 years.\n19. Backfill Cohorts: Participants for whom no curative treatment options, including transplantation, are available.\n20. Historical documented evidence of HLA-A\\*02:01 allele positivity.\n21. ECOG PS score 0-1. Adequate Organ Function Requirements within 10 Days of Treatment Initiation\n22. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73 m2 based on local institutional practice (e.g., Cockcroft-Gault formula).\n23. Adequate liver function defined as:\n\n    * Total bilirubin \\\u003C1.5 × the upper limit of normal (ULN) for age or normal conjugated bilirubin, or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in participants with well documented Gilbert's syndrome or hemolysis or who require regular blood transfusions.\n    * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 × ULN (unless attributed to leukemic or tumor involvement with discussion with the Study Responsible Physician).\n24. If a female of childbearing potential, willing to use a highly effective method of contraception or double barrier method from the time of enrollment through 120 days following the last study drug dose.\n25. If male of childbearing potential, agrees to use barrier contraception from the time of enrollment through 120 days following the last study drug dose.\n26. Participant or participant's health care proxy is able and willing to provide written informed consent and able to follow study instructions.\n\nExclusion Criteria:\n\nCohort C (Recurrent\u002FProgressive GBM) Specific Exclusion Criteria:\n\n1. Known or suspected leptomeningeal disease are excluded, defined as radiographic evidence of leptomeningeal involvement on MRI of the brain and\u002For spine, or positive cerebrospinal fluid (CSF) cytology, at screening or prior to first dose.\n2. Tumors involving the brainstem or spinal cord are excluded, including primary tumors arising from, or metastatic lesions involving, the brainstem (midbrain, pons, or medulla) or spinal cord.\n3. Received prior bevacizumab or any other anti-VEGF or anti-VEGFR therapy.\n4. Absolute lymphocyte count \\\u003C800\u002FuL.\n5. Clinically significant mass effect or midline shift.\n\n   Exclusion Criteria for All Participants:\n6. Previous treatment with any pHLA-targeting T-cell engager.\n7. Isolated extramedullary relapse.\n8. Active central nervous system (CNS) disease. Participants with prior CNS history can be enrolled if the participant has a negative lumbar puncture following completion of intrathecal chemotherapy.\n\n   • Note: this does not apply to Cohort C GBM participants\n9. Known HIV infection.\n10. Active hepatitis B infection (participants with documented clearance following treatment are allowed).\n11. Active hepatitis C infection (participants with documented clearance following treatment are allowed).\n12. Any acute or chronic infection requiring systemic treatment\n13. Pregnant or nursing women: Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n14. Cardiac Disease:\n\n    * Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class \\>II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n    * QTc using Fridericia's correction (QTcF) \\>480 msec\n15. Graft-Versus-Host Disease (GVHD): Active GVHD.\n16. Concurrent malignancy in the previous 2 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy. Concurrent malignancy must be in CR or no evidence of disease (NED) during this timeframe.\n17. Current or historical diagnosis of a gastrointestinal autoimmune or inflammatory condition, including but not limited to ulcerative colitis (UC), Crohn's disease (CD), indeterminate colitis, or microscopic colitis (collagenous or lymphocytic colitis), or a history of GI toxicity from previous therapy that, in the opinion of the investigator, should preclude study participation.\n18. Significant impairment of lung function requiring chronic use of ambulatory supplemental oxygen.\n19. Screening laboratory values or investigations that do not meet the requirements for adequate organ function.\n20. History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate.\n21. Any commercially available or investigational anti-leukemic or anti-cancer therapy other than CBX 663, with the following exceptions:\n\n    • Intrathecal chemotherapy for CNS prophylaxis is permitted after C1 is complete, at the treating physician's discretion.\n22. Participants who experienced severe, life-threatening or recurrent (≥ Grade 2) immune-mediated adverse events or infusion-related reactions including those that led to permanent discontinuation while on previous treatment with immuno-oncology agents.\n23. Any concurrent systemic treatment to prevent GVHD. Topical treatments for GVHD are permitted. Participants who stopped calcineurin inhibitor (CNI) prophylaxis should be off CNI for at least 4 weeks.\n24. Known allergy or sensitivity to study drug, including excipients.",{"count":57,"type":21},120,[24],"This is a Phase 1, open-label, dose-escalation study of CBX-663 in participants with R\u002FR AML, MDS or CMML (Cohort A), advanced solid tumors (Cohort B), or recurrent or progressive GBM (Cohort C) (collectively called 'indication cohorts'). Participants aged ≥18 years are planned to be enrolled. CBX-663 will initially be investigated on a fixed dosing schedule. CBX-663 will be administered intravenously (IV) on Cycle 1 Day 1 (C1D1) and then once weekly (QW) in 21-day cycles. Participants will continue treatment with CBX-663 until unacceptable toxicity, progressive disease, withdrawal of consent, or lack of clinical benefit.",[28,61,62],"Recurrent or Progressive Glioblastoma","Relapse or Refractory Myeloid Malignancies","NOT_YET_RECRUITING","2026-08-18",{"date":66,"type":40},"2026-08-21",{"date":68,"type":21},"2026-08",{"date":70,"type":21},"2028-06",{"name":72,"class":47},"Crossbow Therapeutics, Inc.",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":73},"100652636","phase-1-hs-20117-2-injection-in-patients-with-advanced-solid-tumors-100652636","NCT07775703","HS-20117-2 Injection in Patients With Advanced Solid Tumors","A Phase I Clinical Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of HS-20117-2 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 to 75 years, male or female.\n2. According to RECIST v1.1, the investigator assesses that the participant has at least one target lesion.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 1, with no deterioration within 2 weeks prior to the first dose.\n4. Minimum life expectancy greater than 12 weeks.\n5. Female patients of childbearing potential, from signing the informed consent until 6 months after the last dose, are willing to adopt appropriate contraceptive measures and should not be breastfeeding; male patients, from signing the informed consent until 6 months after the last dose, are willing to use barrier contraception (i.e., condoms).\n6. Female patients must have a negative blood pregnancy test result within 7 days prior to the first dose, or demonstrate no risk of pregnancy.\n7. Voluntarily participate in this clinical trial, understand the study procedures, and be capable of providing written informed consent.\n\nExclusion Criteria:\n\n1. Presence of prior anti-tumor therapy-related toxicities with a severity ≥ Grade 2 (according to CTCAE v5.0), excluding alopecia and neurotoxicity.\n2. Meeting any of the following cardiac criteria:\n\n   1. Mean QT interval corrected by Fridericia's formula (QTcF) \\> 470 msec on resting ECG.\n   2. Resting ECG abnormalities indicating clinically significant rhythm, conduction, or morphological abnormalities as judged by the investigator (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval \\> 250 msec).\n   3. Presence of any factor that increases the risk of QT prolongation or arrhythmic events judged by the investigator as clinically significant (e.g., heart failure, refractory hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong the QT interval).\n   4. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n3. Presence of severe, uncontrolled, or active cardiovascular or cerebrovascular diseases.\n4. Severe or poorly controlled hyperglycemia.\n5. Severe or poorly controlled hypertension.\n6. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose of study treatment.\n7. History of severe arterial or venous thrombotic events within 3 months prior to the first dose of study treatment.\n8. Ongoing or active infection within 4 weeks prior to the first dose of study treatment.\n9. Current or anticipated requirement for long-term (≥ 30 days) systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) within 30 days prior to enrollment, except for patients requiring chronic inhaled corticosteroids for asthma or topical corticosteroid use. History of immunodeficiency, other acquired or congenital immunodeficiency diseases, or history of organ transplant or allogeneic bone marrow transplantation (excluding corneal transplant).\n10. Presence of active infectious diseases.\n11. History of hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.\n12. Presence of interstitial lung disease (ILD). Evidence of active pneumonia on chest imaging during screening. Patients requiring long-term continuous oxygen therapy.\n13. Severe neurological or psychiatric disorders that may interfere with study evaluation.\n14. Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study or within 6 months after the last dose of the investigational product.\n15. History of severe allergies, or known hypersensitivity to any component of HS-20117 or drugs in the same class as HS-20117.\n16. Patients judged by the investigator as likely to have poor compliance with the study procedures and requirements.\n17. Any condition that, in the investigator's judgment, jeopardizes patient safety or interferes with the study evaluation.","75 Years",{"count":83,"type":21},60,[24],"This trial is a multicenter, open-label, Phase I clinical study designed to evaluate the pharmacokinetics, safety, and tolerability of HS-20117-2 in patients with advanced solid tumors.",[28],{"date":39,"type":40},{"date":89,"type":40},"2025-11-13",{"date":91,"type":21},"2027-12-30",{"name":93,"class":47},"Hansoh BioMedical R&D Company",{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100652475","phase-1-an-open-label-study-of-sg1827-combined-with-anti-pd-1pd-l1-antibody-and-bevacizumab-in-patients-with-advanced-solid-tumors-100652475","NCT07774611","An Open-label Study of SG1827 Combined With Anti-PD-1\u002FPD-L1 Antibody and Bevacizumab in Patients With Advanced Solid Tumors","A Phase 1b\u002F2 Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SG1827 for Injection in Combination With Anti-PD-1\u002FPD-L1 Antibody and Bevacizumab in Patients With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years, male or female.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n3. Life expectancy ≥3 months.\n4. Histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor. Participants enrolled in the dose escalation phase must have received prior systemic therapy, with disease progression or intolerance to the last line of treatment.\n5. At least one measurable lesion per RECIST 1.1 criteria.\n6. Adequate organ and bone marrow function.\n7. Female participants of childbearing potential and male participants with partners of childbearing potential must use at least one accepted method of contraception during the study treatment period and for at least 5 months (150 days) after the last dose.\n8. Male participants must refrain from sperm donation from the time of signing the informed consent form (ICF) until at least 5 months after the last dose.\n\nExclusion Criteria:\n\n1. Prior treatment with immunotherapies targeting CTLA 4 and\u002For CD28 (or agents containing these targets).\n2. Presence of active central nervous system (CNS) metastatic lesions.\n3. Other malignant tumors within 5 years prior to the first dose.\n4. Receipt of any of the following treatments or procedures:\n\n   1. Major surgery (other than diagnostic biopsy) within 28 days prior to the first dose;\n   2. Anti tumor macromolecular antibody therapy or other unmarketed investigational anti tumor therapies within 28 days prior to the first dose; anti tumor chemotherapy, endocrine therapy, or oral small molecule targeted therapy within 14 days prior to the first dose; traditional Chinese medicine preparations approved by the NMPA with anti tumor indications within 7 days prior to the first dose;\n   3. Curative radiotherapy within 28 days prior to the first dose; palliative radiotherapy is permitted within 14 days prior to the first dose, provided that all related AEs have resolved to ≤ Grade 1 (CTCAE v6.0), except for toxicities such as alopecia that are judged by the investigator to have no safety risk and not to violate other inclusion\u002Fexclusion criteria;\n   4. Vaccination with any live vaccine within 28 days prior to the first dose, or planned vaccination with any live vaccine during the study treatment period;\n   5. History of allogeneic organ transplantation or allogeneic stem cell transplantation.\n5. Use of systemic corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose or during the study period.\n6. Active infection requiring intravenous or oral antibiotic therapy within 14 days prior to the first dose, with the exception of prophylactic use.\n7. Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.\n8. Participants with active hepatitis B or hepatitis C, or human immunodeficiency virus (HIV) infection.\n9. Known allergy to any component of the study drug, or history of Grade 3 4 allergic reactions to any biologic product, or history of life threatening hypersensitivity.\n10. Immune related adverse reactions that led to permanent discontinuation of prior anti tumor immunotherapy.\n11. Current or prior history of idiopathic pulmonary fibrosis or idiopathic pneumonia; current active pulmonary disease, interstitial lung disease or pneumonitis (excluding radiation induced localized interstitial pneumonia), pulmonary fibrosis, etc.; history of tracheal fistula; severe dyspnea, pulmonary insufficiency, or requiring continuous oxygen supplementation.\n12. Uncontrolled pleural, peritoneal, or pericardial effusion requiring repeated drainage or with significant symptoms within 14 days prior to the first dose.\n13. Psychiatric disorders or poor compliance.\n14. Female participants who are pregnant or breastfeeding.\n15. Any other condition that, in the investigator's opinion, would make the participant unsuitable for participation in the study.",{"count":102,"type":21},180,[24,25],"This multicenter, open-label Phase Ib\u002FII study with dose escalation and expansion in Chinese patients with advanced solid tumors consists of Part A (SG1827 plus anti-PD-1\u002FPD-L1) and Part B (SG1827 plus anti-PD-1\u002FPD-L1 and bevacizumab), both evaluating safety, tolerability, PK\u002FPD, immunogenicity, and antitumor efficacy.",[28],"2026-08-17",{"date":37,"type":40},{"date":109,"type":21},"2026-09-22",{"date":111,"type":21},"2028-12-31",{"name":113,"class":47},"Hangzhou Sumgen Biotech Co., Ltd.",10,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":132,"locationsCount":134},"100527200","phase-1-gt201-injection-for-the-treatment-of-advanced-solid-tumors-100527200","NCT06144671","Phase I\u002FII Clinical Study of GT201 Injection as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors","Phase I\u002FII Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201 Injection) as Monotherapy or in Combination With PD-1 Inhibitor for Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily enroll in the study, sign the informed consent form (ICF), and be willing and able to comply with the study protocol.\n* 2\\. Aged 18 to 70 years old. For subjects older than 70 years old, eligibility shall be jointly determined by the Investigator and the Sponsor's Medical Monitor.\n* 3\\. Diagnosis:\n\n  * Phase I trial: Patients with advanced solid tumors who have failed standard therapy, have no available standard therapy, or cannot tolerate standard therapy.\n  * Phase II trial: Patients with the target indication who have progressed or are intolerant after receiving the specified treatment outlined in the protocol, and who meet the inclusion and exclusion criteria for the target indication.\n* 4\\. At least one lesion that is resectable for the preparation of autologous TIL cells.\n* 5\\. At least one measurable lesion that meets the definition of RECIST v1.1 after tumor sampling.\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* 7\\. Estimated survival time ≥ 12 weeks.\n* 8\\. Functions of major organs meet the requirements specified in the protocol.\n* 9\\. Female or male subjects of childbearing potential who have not undergone surgical sterilization must agree to use at least one medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for 1 year after the end of study treatment. For female subjects of childbearing potential without surgical sterilization, serum human chorionic gonadotropin (hCG) test must be negative within 7 days prior to cell infusion.\n* 10\\. Prior treatment related adverse events shall have recovered to Grade ≤ 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 before tumor sampling, or be judged by the investigator together with the sponsor's medical monitor not to interfere with the study.\n* 11\\. For participants enrolled in this study due to disease progression, imaging documentation confirming disease progression following the prior therapy must be available before tumor sampling.\n\nExclusion Criteria:\n\n* 1\\. Patients with spinal cord compression not relieved by surgery and\u002For radiotherapy are excluded. (Patients may be enrolled if clinical evidence confirms symptom relief for ≥ 1 week prior to tumor harvesting.)\n* 2\\. Participants with uncontrolled tumor related pain as judged by the investigator. Participants requiring analgesic medications must have a stable analgesic regimen at study entry. Symptomatic lesions suitable for palliative radiotherapy should have completed treatment prior to study entry.\n* 3\\. Bleeding events within 3 months prior to screening.\n* 4\\. Patients with arterio-venous thrombotic events that occurred within 6 months prior to screening.\n* 5\\. Respiratory disorders that severely impair pulmonary function at screening.\n* 6\\. History of clinically significant cardiovascular disease, including but not limited to:\n\n  1. Congestive heart failure (New York Heart Association \\[NYHA\\] Class \\>grade II);\n  2. Unstable angina pectoris;\n  3. Myocardial infarction within the previous 3 months;\n  4. Any supraventricular or ventricular arrhythmia requiring treatment or intervention.\n* 7\\. Participants with ≥ 3 untreated central nervous system (CNS) metastases.\n* 8\\. Any active autoimmune disease, history of autoimmune disease, or diseases requiring systemic corticosteroids (\\>10 mg prednisone daily or equivalent) or immunosuppressive agents.\n* 9\\. Malignant tumors other than the target indication within 5 years.\n* 10\\. Presence of intractable epilepsy, medically uncontrolled pleural effusion, ascites, pericardial effusion, or any contraindication to IL-2 administration.\n* 11\\. Active infectious diseases within 1 year prior to screening, such as HIV infection, syphilis, active hepatitis, active pulmonary tuberculosis, active Epstein-Barr virus (EBV) and\u002For cytomegalovirus (CMV) infection; OR history of active pulmonary tuberculosis infection more than 1 year ago without standard treatment; active hepatitis B or hepatitis C.\n\n  * Participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) may enroll if HBV DNA level is below the lower limit of quantification (LLOQ) of the local study laboratory.\n  * Participants positive for HCV antibody may enroll if HCV RNA level is below the LLOQ of the local study laboratory.\n  * Participants with EBV DNA above the laboratory LLOQ may enroll if the Investigator assesses the viremia is tumor-related and the infection is non-active.\n  * Carriers enrolled in the study shall receive antiviral therapy at the Investigator's discretion, with regular quantitative nucleic acid testing scheduled throughout the study period.\n* 12\\. Use of anti angiogenic agents such as bevacizumab within 4 weeks before surgical sampling.\n* 13\\. Previous allogeneic bone marrow transplantation or solid organ transplantation.\n* 14\\. Receipt of systemic anti tumor therapy within 4 weeks prior to lymphodepleting chemotherapy, except for the following:\n\n  * Bridging therapy;\n  * If prior chemotherapy with nitrosoureas or mitomycin C was administered, an interval of no less than 6 weeks between the end of such chemotherapy and the anticipated date of lymphodepleting chemotherapy is required for enrolment;\n  * If prior small molecule targeted therapy was administered, an interval of no less than 5 half lives of the agent between the end of such therapy and the anticipated date of lymphodepleting chemotherapy is required for enrolment.\n* 15\\. Prior receipt of genetically modified or gene edited cell therapy products (excluding non genetically modified autologous immune cell therapy products administered more than 1 year before the date of cell infusion).\n* 16\\. History of hypersensitivity reaction to any component of investigational products to be used in the study, including but not limited to autologous TIL, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran 40, antibiotics (β-lactam antibiotics, gentamicin).\n* 17\\. Known psychiatric illness, alcoholism, drug addiction or substance abuse.\n* 18\\. Prior immune therapy related adverse events of Grade 3 or higher that have not recovered to CTCAE Grade 1 or less within 28 days; or any other disease or medical condition (any other illness, metabolic disorder, physical finding abnormality or laboratory abnormality) that would raise reasonable concerns prohibiting the use of investigational product, confound the interpretation of study results, or place the participant at high risk of treatment related complications.\n* 19\\. Pregnant or lactating women; or women with plans for pregnancy, conception or lactation within 1 year after the end of study treatment.\n* 20\\. Receipt of other investigational medicinal products within 4 weeks prior to lymphodepleting chemotherapy, or plan to receive other investigational medicinal products during the study.\n* 21\\. Other conditions deemed ineligible for enrollment at the investigator's discretion.","70 Years",{"count":124,"type":21},78,[24,25],"This is a multicenter Phase I\u002FII clinical trial. It aims to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of GT201 in patients with advanced solid tumors.",[28],{"date":37,"type":40},{"date":130,"type":40},"2025-11-01",{"date":91,"type":21},{"name":133,"class":47},"Grit Biotechnology",2,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100577497","phase-1-first-in-human-study-of-atx-295-an-oral-inhibitor-of-kif18a-in-patients-with-advanced-or-metastatic-solid-tumors-including-ovarian-cancer-100577497","NCT06799065","First-in-Human Study of ATX-295, an Oral Inhibitor of KIF18A, in Patients With Advanced or Metastatic Solid Tumors, Including Ovarian Cancer","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-295, an Oral Inhibitor of the Kinesin Motor Protein KIF18A, in Patients With Locally Advanced or Metastatic Solid Tumors, Including High-Grade Serous Ovarian Cancer","Key Inclusion Criteria:\n\n* Patients with histologically confirmed solid tumors who have locally recurrent or metastatic disease, including HGSOC\n* Refractory to or relapsed after all standard therapies with proven clinical benefit, unless as deemed by the Investigator, the subject is not a candidate for standard treatment, there is no standard treatment, or the subject refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit\n* For the expansion cohorts, participants must have histological confirmation of HGSOC and be determined to be platinum-resistant, platinum-refractory, or platinum-intolerant\n* There is no limit to the number of prior treatment regimens\n* Have measurable or evaluable disease\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nKey Exclusion Criteria:\n\n* Clinically unstable central nervous system (CNS) tumors or brain metastasis\n* Any other concurrent anti-cancer treatment, except for hormonal blockade\n* Has undergone a major surgery within 3 weeks of starting study treatment\n* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of ATX-295, however participants with a functioning distal ileostomy or colostomy may be permitted on trial\n* Clinically significant (ie, active) or uncontrolled cardiovascular disease\n* Need to use proton pump inhibitors on study or H2-receptor antagonists for the dose escalation portion of the study.\n* Unable to transition off strong or moderate CYP3A4 inhibitors or strong inducers\n* Pregnancy or intent to breastfeed or conceive a child within the projected duration of treatment\n\nOther inclusion and exclusion criteria as defined in the study protocol",{"count":143,"type":21},90,[24],"The goal of this study is to identify a safe and tolerated dose of the orally administered KIF18A inhibitor ATX-295. In addition, this study will evaluate the pharmacokinetics, pharmacodynamics and preliminary antitumor activity of ATX-295 in patients with advanced solid tumors and ovarian cancer.",[28,147,148,149,150],"Breast Cancer Recurrent","Ovarian Cancer","High-grade Serous Ovarian Carcinoma","Triple Negative Breast Cancer",[152,153,154,155,156,157],"KIF","KIF18A","HGSOC","Platinum-resistant","Platinum-intolerant","Platinum-refractory","2026-08-15",{"date":64,"type":40},{"date":161,"type":40},"2025-03-21",{"date":163,"type":21},"2027-08-30",{"name":165,"class":47},"Accent Therapeutics",9,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":186,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":134},"100379579","phase-1-metarrestin-ml-246-in-subjects-with-metastatic-solid-tumors-100379579","NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1 (Phase IB only).\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  * Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  --a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  --Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\\*\n\n  ---\\\u003C 1.5x institution upper limit of normal OR\n\n  ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n\n  \\*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight: \\>= 35 kg (\\>= 18 years old) or \\>=40 kg (\\>= 12 and \\\u003C 18 years old).\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease.\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","12 Years","120 Years",{"count":177,"type":21},116,[24],"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.",[28,181,182,183,184,185],"Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms",[187,188,189,190,191],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose",{"date":64,"type":40},{"date":194,"type":40},"2020-10-27",{"date":111,"type":21},{"name":197,"class":198},"National Cancer Institute (NCI)","NIH",{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100652421","phase-1-vbc117first-in-human-trial-of-vbc117-in-participants-with-advanced-malignant-solid-tumors-100652421","NCT07772934","VBC117First-in-Human Trial of VBC117 in Participants With Advanced Malignant Solid Tumors","Phase 1\u002F2a Open-label Clinical Trial Evaluating VBC117, an EGFR and CDH17-directed Bi-specific Antibody Drug Conjugate, in Participants With Advanced Malignant Solid Tumors","Inclusion Criteria:\n\n1. The participant or the participant's legally acceptable representative is willing and able to provide a written ICF before initiating any trial procedure.\n2. Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor .\n3. At least one measurable lesion as assessed by the investigator according to RECIST v1.1 criteria.\n4. Male or female adults (defined as ≥ 18 years of age).\n5. ECOG performance status 0-1.\n6. Life expectancy greater than 12 weeks.\n7. Archived tumor tissue sample available or able to undergo a fresh biopsy collection.\n8. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Any unresolved toxicity of Grade ≥2 from previous anti-cancer treatment.\n2. Known or suspected brain metastases, or spinal cord compression.\n3. Prior treatment with an ADC targeting EGFR x CDH17 bispecific ADC.\n4. Prior treatment with any ADC carrying a topoisomerase I inhibitor (TOP1i) payload.\n5. Has a medical history of interstitial lung diseases or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.",{"count":207,"type":21},260,[24,25],"Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1\u002F2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and\u002For recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.",[28],[28,212,213,214,215],"VBC117","Phase 1","Phase 2a","Dose Escalation","2026-08-14",{"date":37,"type":40},{"date":219,"type":21},"2026-08-24",{"date":221,"type":21},"2029-05-28",{"name":223,"class":47},"VelaVigo Bio Inc",12,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":166},"100620645","phase-1-anti-ly6e-exatecan-adc-m7437-in-advanced-solid-tumors-100620645","NCT07360314","Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors","A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants have histologically proven advanced solid tumors with known prevalent and high Ly6E expression, Disease characteristic: Participants should have an unresectable locally advanced or metastatic solid tumor that is refractory to standard therapies, or have no standard therapies, or for which no standard therapy is judged appropriate by the Investigator.\n\nFor each tumor type, participants have received prior lines of therapy, where locally available:\n\n* Non-small cell lung cancer (nonsquamous or squamous)\n* Triple-negative breast cancer\n* Squamous cell carcinoma of head and neck\n* Pancreatic ductal adenocarcinoma\n* Gastric cancer\n* Epithelial ovarian cancer\n\n  * Participants with ECOG Performance Status (ECOG) less than and equal to (\\\u003C=) 1\n  * Participants must have blood, liver, and kidney function within safe levels.\n  * Other protocol defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Participant has a history of another malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm\u002Fhyperplasia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years before the date of enrollment). History of hematopoietic allogenic transplantation.\n* Participants with known brain metastases, except those meeting both of the following criteria:\n\n  1. All brain metastases have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment.\n  2. No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).\n* Participants with diarrhea (liquid stool) or ileus Grade more than (\\>) 1 within 1 week of Cycle1Day1.\n* Participants with active chronic inflammatory bowel disease and\u002For bowel obstruction.\n* Participants with history of serious gastrointestinal bleeding within 3 months of Cycle1Day1.\n* Other protocol defined exclusion criteria may apply.",{"count":233,"type":21},138,[24],"The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, Pharmacokinetics (PK), and preliminary clinical activity of M7437 in participants with locally advanced or metastatic solid tumors with known Ly6E expression, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), epithelial ovarian carcinoma (EOC), squamous cell carcinoma of the head and neck (SCCHN), pancreatic ductal adenocarcinoma (PDAC), and gastric cancer (GC).",[28],[238,239,240,241,242,243,244,245,246],"Ly6E expression","Topoisomerase I inhibitor (TOP1i)","NSCLC","Breast cancer","Gastric cancer","Head and neck squamous cell carcinoma","Ovarian cancer","Pancreatic ductal adenocarcinoma","Systemic antibody-drug conjugate therapy (ADC) therapy","2026-08-13",{"date":106,"type":40},{"date":250,"type":40},"2026-02-13",{"date":252,"type":21},"2029-03-28",{"name":254,"class":47},"EMD Serono Research & Development Institute, Inc.",{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":22,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100576996","phase-1-a-phase-i-study-of-sim0505-in-participants-with-advanced-solid-tumors-100576996","NCT06792552","A Phase I Study of SIM0505 in Participants With Advanced Solid Tumors","A Phase I First-in-human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Written informed consent is obtained prior to any procedures that are not considered standard of care.\n2. ≥18 years of age.\n3. In Part 1:\n\n   1. Participants with histologically or cytologically confirmed advanced solid tumors, who have failed or are ineligible for standard of care therapies.\n   2. Have progressed on at least one prior systematic anti-tumor regimen, and presence of at least one evaluable lesion according to RECIST Version 1.1. Measurable lesions are required in the backfill period.\n   3. In the backfill period, eligible tumor types are limited to high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, USC, clear cell RCC, papillary RCC and adenocarcinoma of NSCLC without actionable mutation of epidermal growth factor receptor (EGFR). For participants with NSCLC, presence of CDH6 expression through immunohistochemical examination of tumor tissue by central laboratory is required.\n4. In Part 2: Participants must have a diagnosis of specific type of metastatic or locally advanced solid tumors and have progressed on or cannot benefit from the most recent systematic anti-tumor regimen (unless otherwise specified), with presence of at least one measurable lesion according to RECIST Version 1.1.\n\n   Platinum-resistant ovarian cancer cohort:\n   1. Participants with histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   2. Have platinum-resistant disease, defined as: participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a best response of CR or PR, and then progressed between \\>90 days and ≤180 days after the date of the last dose of platinum; participants who have received ≥2 lines of platinum therapy must have progressed ≤180 days after the date of the last dose of platinum.\n   3. At least one line of therapy containing anti-VEGF therapy (e.g., bevacizumab or suvemcitug or their biosimilar), unless the participant is not eligible for treatment with anti- angiogenic treatment due to precautions\u002Fintolerance. Has had prior poly-ADP ribose polymerase (PARP) inhibitors for subjects with documented breast cancer gene (BRCA) mutation (germline and\u002For somatic), unless the subject is not eligible for treatment with a PARP inhibitor. Has had prior treatment with mirvetuximab soravtansine for participants with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with mirvetuximab soravtansine due to precautions\u002Fintolerance, or if the treatment is not approved or available locally. In the PROC cohort, topoisomerase inhibitor payload ADC-pretreated participants should have received at least one prior topoisomerase inhibitor payload ADC.\n\n   Renal cell carcinoma cohort:\n   1. Participants with histologically- or cytologically-confirmed clear cell RCC or papillary RCC.\n   2. For clear cell RCC: Participants who have progressed on or after systemic treatment including a programmed cell death protein 1 or programmed death ligand 1 (PD-1\u002FPD-L1) checkpoint inhibitor and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI), either given concurrently or in separate lines of therapy.\n   3. For papillary RCC: Participants without any prior systemic treatment is acceptable.\n\n   Uterine serous carcinoma cohort:\n   1. Participants with histologically- or cytologically-confirmed USC.\n   2. Have progressed on or after systemic treatment that contained platinum-based chemotherapy.\n\n   Non-Small Cell Lung Cancer cohort:\n   1. Participants with histologically- or cytologically-confirmed adenocarcinoma of NSCLC without actionable mutation of EGFR.\n   2. Presence of CDH6 expression through immunohistochemical examination of tumor tissue.\n   3. For participants without actionable mutations: Have progressed on or after systemic treatment including anti-PD-1\u002FPD-L1 antibody and platinum-based chemotherapy, either given concurrently or in separate lines of therapy. Progression within 6 months after completion of adjuvant therapy is considered failure of first-line therapy.\n   4. For participants with actionable mutations other than EGFR: Have failed at least one established standard anti-cancer targeted therapy, anti-PD-1\u002FPD-L1 antibody and platinum-based chemotherapy (PD-1\u002FPD-L1 and chemotherapy either given concurrently or in separate lines of therapy) or in the opinion of the Investigator have been considered ineligible for a particular form of standard of care therapy on medical grounds.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n6. Life expectancy of ≥12 weeks.\n7. Have adequate organ function as indicated by the laboratory values listed within the protocol.\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study treatment. WOCBP or male participants who have sexual relations with WOCBP are required to use highly effective contraceptive methods, and agree to refrain from donating sperm\u002Fegg from signing of informed consent through 180 days after the last dose of study treatment.\n9. Able to provide tumor tissue sample (archival or newly obtained core or excisional biopsy). For Part 1: At biomarker-screening (for NSCLC) or screening (for non-NSCLC) visit of a tumor lesion not previously irradiated for CDH6 testing.\n\nFor Part 2: Willing to undergo fresh tumor biopsy at biomarker-screening visit (for NSCLC) and screening visit (non-NSCLC) from a lesion that can be biopsied at an acceptable clinical risk as judged by the investigator.\n\nExclusion Criteria:\n\n1. For Part 2: has clear cell, mucinous or sarcomatous histology, mixed tumors containing any histology, or low-grade\u002Fborderline ovarian cancer; mixed nonsmall cell and small cell carcinoma, or adenosquamous cell lung cancer with an adenocarcinoma component \\\u003C50% (the participant is eligible if the adenocarcinoma component is ≥50%).\n2. For Part 2: Participants with primary platinum refractory ovarian cancer, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.\n3. Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n4. Known untreated CNS metastases and\u002For leptomeningeal metastases. Participants are eligible if CNS metastases have been treated and participants have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior to the first dose of study treatment. Imaging performed within 28 days prior to the first dose of study treatment must document radiographic stability of CNS lesions and be performed after completion of any CNS-directed therapy.\n5. History of bowel obstruction within 3 months prior to the first dose of study treatment.\n6. Known psychiatric disorder or drug abuse that would interfere the study requirements.\n7. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment.\n8. Any active infection requires systemic treatment via intravenous infusion within 2 weeks prior to the first dose of study treatment.\n9. History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease.\n10. Prior exposure to other CDH6-targeted agents.\n11. Prior exposure to an ADC with a topoisomerase I inhibitor payload (e.g., raludotatug deruxtecan\u002FDS-6000) for all cohorts except for the topoisomerase inhibitor payload ADC-pretreated participants in PROC cohort.\n12. Has not recovered (i.e., to CTCAE version 5.0 Grade 1 or to baseline) from previous anticancer therapy-induced AEs. Grade ≤2 AEs with no impact on participant safety are exceptions to this criterion and may qualify for the study.\n13. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of SIM0505.\n14. Major surgery within 2 weeks of receiving the first dose of study treatment.\n15. Has received prior anti-cancer therapies within the following time frames prior to the first dose of study treatment: previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors), hormonal agents within 2 weeks; anti-cancer antibody or ADC within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study treatment; Chinese medicines\u002Fherbal preparations with anticancer indication taken within 2 weeks; and\u002For radiation therapy within 2 weeks for focal radiation or within 4 weeks for wide-field radiation.\n16. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.\n17. Administration of strong or moderate CYP3A4 inhibitors or drugs with known risk of Torsades de Pointes (TdP) ≤ 7 days or 3 half-lives (whichever is longer) prior to the first dose of SIM0505.\n18. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).\n19. Active hepatitis B or hepatitis C infection.\n20. Participants with clinically significant cardiovascular diseases.\n21. History of allogeneic organ transplantation or graft-versus-host disease.\n22. Known hypersensitivity to study drug or any of the excipients.\n23. Participant is pregnant or breastfeeding.\n24. Other conditions that researchers consider inappropriate for inclusion.",{"count":263,"type":21},738,[24],"This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors",[28,267,268,269,270,271,272,273],"Platinum Resistant Ovarian Cancer","Fallopian Tube Cancer","Renal Cell Carcinoma (RCC)","Papillary Renal Cell Carcinoma (Prcc)","Uterine Serous Carcinoma (USC)","NSCLC (Non-small Cell Lung Cancer)","Primary Peritoneal Cancer",{"date":106,"type":40},{"date":276,"type":40},"2025-02-26",{"date":278,"type":21},"2028-08",{"name":280,"class":47},"NextCure, Inc.",17,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100516417","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-anti-tumor-activity-of-vvd-133214-as-monotherapy-and-in-combination-in-participants-with-advanced-solid-tumors-100516417","NCT06004245","A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors","A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Harboring Microsatellite Instability (MSI) and\u002For Deficient Mismatch Repair (dMMR)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Have a microsatellite instability (MSI) and\u002For deficient mismatch repair (dMMR), histologically or cytologically documented advanced (unresectable and\u002For metastatic) solid tumor; For the combination with bevacizumab only: advanced, or metastatic colorectal adenocarcinoma (CRC) treated with at least 2 but no more than 3 prior lines of systemic therapy for the treatment of advanced CRC; For the combination with pembrolizumab only: Histologically confirmed locally advanced, or metastatic CRC with no prior systemic treatment for metastatic disease and not amenable to surgery\n* Have received and then progressed following, or are intolerant to, standard therapy in the advanced setting\n* Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Life expectancy of at least (≥)12 weeks\n* Availability of formaldehyde-fixed paraffin-embedded (FFPE) archival tumor tissue for submission to Sponsor\u002Fcentral laboratory for retrospective central testing; for participants without archival tissue, a biopsy from either primary or metastatic tumor lesion, deemed medically feasible, must be taken\n* Adequate hematologic, end-organ, and cardiovascular function, as defined in the protocol\n\nExclusion Criteria:\n\n* Inability or unwillingness to swallow pills\n* Malabsorption syndrome or other condition that would interfere with enteral absorption\n* Known hypersensitivity or intolerance to ingredients from the study drug formulation including patients with rare genetic disorders such as galactosaemia, glucose-galactose intolerance or congenital lactase deficiency\n* Known uncontrolled central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control) and\u002For carcinomatous meningitis\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis and atypical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds), or any major episode of infection requiring treatment with intravenous antibiotics or hospitalization within 2 weeks prior to the start of drug administration (related to the completion of the course of antibiotics, except if for tumor fever) or 6 months for any intracranial abscess\n* Has a positive test at screening for hepatitis B virus, hepatitis C virus, or for human immodeficiency virus (HIV), per local diagnostic standard and in accordance with local laws and regulations\n* Uncontrolled diabetes or symptomatic hyperglycemia (i.e., well controlled defined as a screening hemoglobin A1c \\\u003C8% and no urinary ketoacidosis)\n* Significant cardiovascular\u002Fcerebrovascular disease within 6 months prior to Day 1 of study drug administration\n* Alcohol or drug dependence or abuse\n* Patients with known Werner (WRN) syndrome\n* Prior treatment with any WRN helicase inhibitor\n* Treatment with moderate or strong CYP3A4 inducers within 14 days prior to initiation of study treatment\n* Treatment with moderate or strong CYP3A4 or P-glycoprotein inhibitors within 14 days prior to initiation of study treatment\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study\n\nAdditional Exclusion Criteria for the Combination with Bevacizumab Only:\n\n* Had major surgery within 4 weeks prior to study drug administration\n* Deep venous thrombosis (DVT) or pulmonary embolism (PE) within 12 weeks prior to study drug administration\n* Known coagulopathy that increases the risk of bleeding\n* Patients with Grade 2+ proteinuria (exception: if 24-hour urinary protein is less than 1.0 gm\u002F24 hours)\n\nAdditional Exclusion Criteria for the Combination with Pembrolizumab Only:\n\n* Active or history of autoimmune disease or immune deficiency with some exceptions\n* History of interstitial lung disease or pneumonitis\n* Treatment with systemic immunosuppressive medication (such as corticosteroids) within 2 weeks prior to initiation of study treatment with some exceptions\n* Treatment with organ transplant\u002Fgraft tissue",{"count":290,"type":21},280,[24],"This is a first-in-human, Phase I, open-label, multicenter, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of VVD-133214 monotherapy, and in combination with bevacizumab or pembrolizumab, in participants with microsatellite instability (MSI) and\u002For deficient mismatch repair (dMMR) advanced solid tumors. VVD-133214 is an oral drug that acts on a protein called Werner (WRN), which may promote the growth of cancers that are MSI and\u002For dMMR. By acting on WRN, VVD-133214 may be able to block the growth of these types of cancer.",[28,294],"Colorectal Cancer",[296,297,298,299],"Deficient mismatch repair","dMMR","Microsatellite instability","MSI",{"date":106,"type":40},{"date":302,"type":40},"2024-01-25",{"date":304,"type":21},"2027-05-31",{"name":306,"class":47},"Vividion Therapeutics, Inc.",43,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":22,"phases":317,"briefSummary":318,"conditions":319,"keywords":320,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":331},"100641429","phase-1-a-phase-i-study-of-cs5007-in-participants-with-advanced-solid-tumors-100641429","NCT07622524","A Phase I Study of CS5007 in Participants With Advanced Solid Tumors","A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti Tumor Activities of CS5007, a Novel EGFR and HER3 Bispecific Antibody-Drug Conjugate, in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Evidence of a personally signed and dated informed consent document.\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Being ≥ 18 years of age on the day of signing informed consent.\n* Pathologically or cytologically confirmed, unresectable advanced solid tumors.\n* Participants must have at least one measurable lesion according to RECIST Version1.1.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.\n* Adequate organ function.\n* Life expectancy ≥ 3 months.\n* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration\n\nExclusion Criteria:\n\n* Has disease that is suitable for local treatment administered with curative intent.\n* Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.\n* Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy.\n* Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose.\n* Has uncontrolled pleural effusion, pericardial effusion, or ascites.\n* Has immune deficient disease or received systemic immunosuppressive treatment.\n* Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea.\n* Has history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids.\n* Has active infections requiring systemic therapy.\n* Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose.\n* Insufficient washout from prior anti-tumor therapy.\n* Received live vaccine within 28 days prior to first dose.\n* History of allogeneic organ or hematopoietic stem cell transplantation.\n* History of hypersensitivity to excipients of study drug or any monoclonal antibody.\n* Any toxic effects of prior therapy unresolved to Grade ≤1.\n* Active alcohol or drug abuse.\n* Pregnant or breastfeeding women.\n* Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.",{"count":316,"type":21},310,[24],"This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.",[28],[321,322,323,35,28],"EGFR","HER3","Bispecific Antibody-Drug Conjugate","2026-08-12",{"date":216,"type":40},{"date":327,"type":40},"2026-07-16",{"date":329,"type":21},"2029-01",{"name":46,"class":47},7,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":344,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":345,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":352},"100613425","phase-1-a-study-of-otp-01-a-dual-paratopic-pd-1vegfr2-antibody-in-patients-with-advanced-solid-tumors-100613425","NCT07266428","A Study of OTP-01, a Dual Paratopic PD-1\u002FVEGFR2 Antibody, in Patients With Advanced Solid Tumors","Phase 1\u002F2A Study of OTP-01, a Dual Paratopic PD-1\u002FVEGFR2 Antibody, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors.\n\n   1. For dose escalation cohort patients: patients must have a tumor type as defined in the protocol. Patients will have progression on or after or intolerance to most recent systemic therapy. Patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. The reason for treatment decline must be clearly documented in the medical record.\n   2. For backfill cohorts: patients must have a tumor type as defined in the protocol. If patients decline an available standard therapeutic regimen known to confer benefit to enroll on this study, the discussion must be clearly documented in the medical record.\n2. Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible.\n3. ECOG performance status 0-1.\n4. Life expectancy of at least 3 months.\n5. Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy).\n6. All toxicity resulting from prior cancer therapies must have resolved to NCI CTCAE v5.0 ≤ Grade 1 or pre-therapy baseline with the exception of alopecia or ≤ Grade 2 neuropathy.\n7. Adequate hematological, renal, and hepatic function.\n8. Other protocol-defined inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Receiving systemic corticosteroids at prednisone-equivalent dose of \\> 10 mg\u002Fday within 4 weeks prior to signing consent. Chronic systemic corticosteroid therapy for physiologic replacement (≤ 10 mg\u002Fday of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted\n2. History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibody therapy or allergic reaction to any excipients within the investigational product\n3. History of toxicity requiring permanent discontinuation of prior cancer immunotherapy\n4. Have an active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment)\n5. History of organ or stem cell transplant or need for immunosuppressive treatment\n6. Have proteinuria \\> 2 + (within 7 days prior to initiation of study treatment).\n7. Received any chemotherapy, immunotherapy or investigational anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug\n8. Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug. If previously irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions\n9. Other protocol and subprotocol-defined exclusion criteria apply",{"count":340,"type":21},170,[24,25],"The main goals of this clinical trial are to find out what the best dose of the study drug, OTP-01, is for patients with solid tumors through understanding how it is tolerated and any side effects that it may cause. The trial will also see if OTP-01 causes tumors to shrink and how the body processes OTP-01 by measuring drug levels in the blood.\n\nThe main questions this study aims to answer are:\n\n* What is the recommended dose of OTP-01 for adults with solid tumors?\n* Is OTP-01 safe and tolerable?\n* Does OTP-01 reduce tumor growth?\n\nParticipants will:\n\n* Receive OTP-01 through an infusion into a vein. Doses will be spaced out and never more than once a week.\n* Have blood tests to evaluate safety and drug levels of OTP-01. These will be done often at first and then less frequently as treatment continues.\n* Have radiographic scans of their tumor at baseline and during the study at regular intervals.\n* Have the choice to have an optional tumor biopsy before and after treatment to help researchers understand how OTP-01 affects cancer and the immune system. These biopsies are voluntary and will not affect participation in the study.",[28],[34],{"date":247,"type":40},{"date":347,"type":40},"2025-12-17",{"date":349,"type":21},"2028-12",{"name":351,"class":47},"Ottimo Pharma Limited",14,{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":369,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":375,"locationsCount":377},"100566595","phase-1-first-in-human-study-of-tub-030-in-patients-with-advanced-solid-tumors-100566595","NCT06657222","First in Human Study of TUB-030 in Patients With Advanced Solid Tumors","A Multicenter FIH Dose Escalation and Optimization Phase I\u002FIIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-breastfeeding female aged 18 years or older\n2. Adequate organ function\n3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1\n4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.\n5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.\n6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.\n7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.\n8. Eastern Cooperative Oncology Group (ECOG) 0-1.\n9. Have a life expectancy of \\>12 weeks for disease-related mortality, as evaluated by the INV.\n10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent\n11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.\n12. Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n\\-",{"count":361,"type":21},250,[24,25],"The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are:\n\nTo determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose.\n\nParticipants will:\n\nReceive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms",[28,365,366,240,367,368],"HNSCC","SCLC","TNBC - Triple-Negative Breast Cancer","CRC",[28,240,370],"Head and Neck Cancer",{"date":216,"type":40},{"date":373,"type":40},"2024-12-13",{"date":349,"type":21},{"name":376,"class":47},"Tubulis GmbH",18,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":390,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":4},"100652073","phase-1-a-study-to-evaluate-atx-898-in-participants-with-advanced-solid-tumors-100652073","NCT07767474","A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors","First-in-human Study of ATX-898, as Monotherapy and in Combination With Other Anti-neoplastic Agents, in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has histologically or cytologically confirmed advanced solid tumor malignancy that is metastatic or locally advanced and unresectable\n* Is ≥18 years of age at the time of signing the informed consent form\n* ECOG performance status score of 0 or 1\n* Adequate organ function\n* Must consent to a pre-treatment tumor biopsy (collected during screening or have available archival tumor tissue in the past 5 years.\n\nFor Part 1a (monotherapy dose escalation)\n\n* Has received one or more standard systemic therapies and additional standard therapies are either not available, or participant ineligible for available standard therapies For Part 1b (monotherapy dose expansion)\n* b1: Has platinum-resistant or refractory metastatic ovarian cancer\n* b2: Has recurrent or metastatic gynecologic cancer excluding the cancers eligible for b1\n* b3: Has recurrent advanced or metastatic solid tumor excluding the cancers eligible for b1 or b2\n* Has at least 1 measurable lesion per RECIST 1.1\n\nFor Part 2a (combination dose escalation)\n\n* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status\n* Has received prior therapy in the metastatic For Part 2b (combination dose expansion)\n* Has confirmed HR+ HER2 - (including HER2 low and ultra low) status\n* Treatment-naïve or has received prior therapy in the metastatic setting\n\nExclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancer being studied\n* Has symptomatic CNS metastases at screening or asymptomatic CNS metastases requiring corticosteroids to control symptoms within 28 days prior to the first dose of ATX-898.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, with the exception of alopecia any grade and Grade ≤2 peripheral neuropathy\n* Has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or would prevent, limit, or confound the protocol-specified assessments\n\nCohort Specific:\n\n* For abemaciclib cohorts only: has a history of any events of cardiac etiology that would contraindicate dosing with abemaciclib\n* For ribocicilib only: has history of pneumonitis or interstitial lung disease",{"count":386,"type":21},343,[24,25],"Study ATX-898-101 is a phase 1\u002F2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors. This study consists of 2 parts. Part 1 evaluates ATX-898 as monotherapy and Part 2 evaluates ATX-898 in combination with anti-neoplastic agents of interest. Both parts will consists of a dose escalation portion and a dose expansion portion.",[28],[391,392,393],"locally advanced or metastatic solid tumors","(HR) positive (HR+) breast cancer","HER2 negative (HER2-) breast cancer","2026-08-11",{"date":106,"type":40},{"date":397,"type":21},"2026-08-01",{"date":399,"type":21},"2030-01-31",{"name":401,"class":47},"Antares Therapeutics, Inc",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":429,"locationsCount":431},"100621592","phase-1-a-study-to-investigate-the-effects-of-multiple-doses-of-rezatapopt-on-the-pharmacokinetics-of-metformin-rosuvastatin-repaglinide-and-midazolam-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-100621592","NCT07372625","A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.","A Phase 1, Open-label, 2-part, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation.","Inclusion Criteria:\n\n1. Written informed consent\n2. 18 years and older\n3. ECOG performance status (PS) score of 0 or 1\n4. Confirmed locally advanced or metastatic solid malignancy with a TP53 Y220C mutation identified through a tumor-tissue based (e.g., FoundationOneCDx, PathGroup, Caris WES, MSK IMPACT, TEMPUS) or a liquid-biopsy based (e.g., Caris, MSK Access) NGS molecular test.\n\n   \\- Patients with primary CNS tumors are allowed to enroll\n5. Patients with castration-resistant prostate cancer must have ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analog or inhibitor or orchiectomy (medical or surgical castration)\n6. Adequate organ function\n7. Life expectancy ≥3 months as assessed by the Investigator\n\nExclusion Criteria:\n\n1. Patients with ovarian, breast, lung, or endometrial tumors who are eligible for the PYNNACLE Phase 2 trial (NCT04585750), unless the corresponding cohort in the PYNNACLE trial is closed to enrollment at the time of screening (to avoid overlap with that study).\n2. Treatment, food, or drink with any of the following:\n\n   * Any systemic anticancer therapies, including but not limited to chemotherapy, small molecule, biologic, or hormonal agents from a previous treatment regimen, or investigational anticancer agents from clinical study within 21 days or 5 half-lives (whichever is longer) prior to the first dose of study drugs\n   * Radiotherapy within 14 days of first dose of study drugs. Palliative radiotherapy particularly limited field and stereotactic body radiation therapy to non-target lesions should be allowed.\n   * Inhibitors or inducers of the enzymes and transporters being tested in this study within 14 days of starting study drugs\n   * Sensitive substrates of CYP3A4 or CYP2C8 with a narrow therapeutic index within 14 days of starting study drugs\n   * Herbal preparations\u002Fmedications known to be strong or moderate CYP3A4 inhibitors or inducers or to have other significant potential for interaction with rezatapopt within 14 days of starting study drugs\n   * Foods or drinks with CYP3A inhibition potential (e.g., grapefruit, grapefruit juice, Seville orange juice, pomelos, starfruits) within 14 days of starting study drugs\n3. Known or suspected significant hypersensitivity, intolerance, or allergy to rezatapopt, metformin, rosuvastatin, repaglinide, or midazolam or any of their excipients or medicinal products with similar chemical structures, food, or other substances\n4. Previously untreated brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Patients who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to starting study drugs, there is no evidence of central nervous system disease progression or mild neurologic symptoms, and there is no requirement for chronic corticosteroid therapy.\n5. Stroke or transient ischemic attack within 6 months before screening\n6. Clinically significant, uncontrolled heart diseases currently or within the last 6 months including:\n\n   * QTcF \\>470 msec obtained as the mean from 3 consecutive resting ECGs. A QTcF value corrected for wide QRS \\>120 msec (QTcFBBB) should be used in place of QTcF for patients with non-clinically significant wide QRS \\>120 msec due to a pacemaker or bundle branch block.\n   * Uncontrolled hypertension\n7. Active gastrointestinal disease that may interfere significantly with the absorption, distribution, metabolism, or excretion of study drug\n8. History of prior organ transplant\n9. Presence of other active invasive cancers other than the one treated in this study within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumors considered cured by local treatment\n10. Known, active, uncontrolled hepatitis B virus infection (i.e., viral load above the limit of quantification), hepatitis C virus infection (i.e., viral load above the limit of quantification), or human immunodeficiency virus infection (viral load \\>400 copies\u002FmL of blood). Patients whose viral load is controlled should be on established antiretroviral therapy for at least 4 weeks before receiving their first dose of study drugs.\n11. Patients with a known KRAS single-nucleotide variation (SNV) mutation\n12. Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drugs\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":352,"type":21},[24],"This study aims to evaluate the effects of rezatapopt on the pharmacokinetics of metformin, rosuvastatin, repaglinide, and midazolam in patients with advanced solid tumors harboring a TP53 Y220C mutation.",[413,28],"TP53 Y220C Mutation",[415,416,417,418,419,213,420,421,422,423,424],"Y220C","PC14586","PMV Pharma","PMV","rezatapopt","metformin","rosuvastatin","repaglinide","midazolam","DDI",{"date":324,"type":40},{"date":427,"type":40},"2026-02-04",{"date":44,"type":21},{"name":430,"class":47},"PMV Pharmaceuticals, Inc",5,{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":451},"100592228","phase-1-a-phase-1-study-to-investigate-fp008-in-subjects-with-advanced-solid-tumors-100592228","NCT06990698","A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors","A Phase 1 First-In-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics Activity of FP008 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Signed written ICF and be able to comply with the protocol.\n2. Male and female subjects ≥18 years of age.\n3. Life expectancy of \\>3 months.\n4. Laboratory values for sufficient organ function at screening.\n5. Toxicity from prior antitumor treatment has resolved to ≤Grade 1 as defined by NCI CTCAE v5.0.\n6. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to the start of FP008.\n7. Male or women of childbearing potential, if sexually active, must agree to use contraception considered adequate and appropriate by the investigator during the period of study drug administration and for at least 5 months after the last dose of FP008.\n8. ECOG performance status of 0 to 1.\n9. Histologically or cytologically confirmed malignancy diagnosis and at least one measurable documented advanced\u002Funresectable or metastatic solid tumor as assessed by RECIST v1.1.\n10. Documented progressive disease, refractory\u002Fresistance\u002Fintolerant to standard therapy (documented the reason(s) why they are intolerant to standard therapy by the investigator), or there is no standard therapy.\n\nExclusion Criteria:\n\n1. Subjects who have received other IL-10 agents.\n2. A history of other malignancies other than basal cell carcinoma of skin, squamous cell carcinoma of skin, non-muscle invasive bladder cancer, thyroid papillary carcinoma or carcinoma in situ of the cervix that have been cured for 2 years after effective treatment.\n3. Received live vaccine within 30 days prior to the first dose of FP008.\n4. Not completely recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of FP008.\n5. Known hypersensitivity to either the drug substances or inactive ingredient of FP008.\n6. Subjects with diagnosis of immunodeficiency, organ transplant requiring immunosuppressive therapy, or allogeneic bone marrow or hematopoietic stem cell transplant.\n7. Daily requirement for corticosteroids within 2 weeks prior to first dose of FP008.\n8. Any other medical disorder, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that the investigator considers unsuitable for participation in the study.\n9. Cardiovascular dysfunction or clinically significant cardiac disease.",{"count":440,"type":21},108,[24],"The goal of the phase 1 study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics activity of FP008 in subjects with advanced solid tumors.",[28],{"date":324,"type":40},{"date":446,"type":40},"2025-06-12",{"date":448,"type":21},"2028-09",{"name":450,"class":47},"Zhuhai Fapon Biopharma Co., Ltd.",4,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100580714","phase-1-a-study-of-phst001-in-advanced-solid-tumors-100580714","NCT06840886","A Study of PHST001 in Advanced Solid Tumors","An Open-label, Phase 1a\u002F1b, Dose Escalation and Dose Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PHST001 in Adult Patients With Advanced Relapsed and\u002For Refractory Solid Tumors","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies.\n* Adequate organ function per laboratory testing\n* Pregnancy prevention requirements\n* Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator\u002Fradiology\n* Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale\n\nKey Exclusion Criteria:\n\n* Diagnosis of immunodeficiency\n* History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded.\n* Active known CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks 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 the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant.\n* Received previous treatment with another agent targeting CD24.",{"count":460,"type":21},272,[24],"This is a multi-center, first-in-human (FIH), open-label, Phase 1a\u002F1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and\u002For refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and\u002For refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.",[28,148,464,465,466],"Endometrial Cancer","Cholangiocarcinoma","CNS Tumor",{"date":324,"type":40},{"date":469,"type":40},"2025-03-31",{"date":471,"type":21},"2031-04",{"name":473,"class":47},"Pheast Therapeutics",20,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":494},"100545626","phase-1-safetytolerability-pharmacokinetics-and-efficacy-of-yl211-in-patients-with-advanced-solid-tumors-100545626","NCT06384352","Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors","A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.\n2. Aged ≥18 years.\n3. Be able and willing to comply with protocol visits and procedures.\n4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or\n5. Adequate organ and bone marrow function.\n\nFor Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)\u002F gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.\n\nFor Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting.\n\nFor Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy\n\nFor Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy\n\nFor Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC\n\nExclusion Criteria:\n\n1. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \\[CAR-T\\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed.\n2. Previously received an ADC consisting of a TopoI\n3. Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause).\n4. A history of leptomeningeal carcinomatosis or carcinomatous meningitis\n5. Brain metastasis, except for the following situations:\n\n   Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed\n6. Clinically significant concomitant pulmonary disease, including but not limited to:\n\nA history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that requires steroids, current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening",{"count":483,"type":21},500,[24],"This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)",[28],{"date":247,"type":40},{"date":489,"type":40},"2024-05-01",{"date":491,"type":21},"2031-06-30",{"name":493,"class":47},"MediLink Therapeutics (Suzhou) Co., Ltd.",21,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":511,"locationsCount":513},"100528941","phase-1-study-of-gs-0201-alone-and-in-combination-in-participants-with-advanced-solid-tumors-100528941","NCT06167317","Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety and Tolerability of GS-0201 as Monotherapy and in Combination in Adults With Advanced Solid Tumors","Inclusion Criteria:\n\n* Able to understand and give written informed consent.\n* Assigned female or male at birth, 18 years of age or older, and meet the age of majority\u002Fadulthood per local regulations.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria by investigator assessment.\n* Organ function requirements:\n\n  * Adequate hematologic function\n  * Adequate hepatic function\n  * Creatinine clearance\n  * Coagulation\n* Tissue requirement:\n\n  * Parts A, B, C, and D:\n\n    * Pre-treatment tumor tissue is required.\n  * Parts A and C backfill biopsy cohorts:\n\n    * Individuals must agree to fresh pre- and on-treatment biopsies.\n* Individuals assigned male at birth and individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception\n* Willing and able to comply with the requirements and restrictions in this protocol\n* Part A (GS-0201 Monotherapy Dose Escalation) Inclusion Criteria:\n\n  * Histologically\u002Fcytologically confirmed progressive\u002Fadvanced solid tumors with selected molecular lesions.\n  * Individuals must have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit or have a contraindication to receive the therapy\n* Part B (Dose Expansion) Inclusion Criteria:\n\n  * Disease documented as:\n  * Cohort B1:\n\n    * Histologically or cytologically confirmed progressive\u002Fadvanced selected solid tumor diagnoses harboring defined molecular lesions\n    * Participants may potentially be required to forgo treatment with approved agent(s) to be able to participate in the study\n  * Cohort B2:\n\n    * Histologically or cytologically confirmed progressive\u002Fadvanced solid tumor diagnoses harboring defined molecular lesions not included in Cohort B1\n* Part C (Dose Escalation) Inclusion Criteria:\n\n  * Histologically or cytologically confirmed unresectable locally advanced\u002Fmetastatic selected solid tumors\n* Part D (Dose Expansion) Inclusion Criteria:\n\n  * Disease documented as:\n  * Cohort D1:\n\n    * Histologically or cytologically confirmed unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)\n  * Cohort D2:\n\n    * Recurrent\u002Fpersistent endometrial cancer\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Known hypersensitivity to any of the study drugs, its metabolites, or formulation excipients\n* Requirement for ongoing therapy with or use of any prohibited medications described in the protocol\n* Individuals with myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with findings suggestive of MDS\u002FAML\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of GS-0201\n* The therapies listed below within the specified timeframe:\n\n  * Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal\u002Fbiliary stent, biopsy) \\\u003C 4 weeks prior to planned Cycle 1 Day 1\n  * Immunotherapy or biologic therapy \\\u003C 21 days prior to planned Cycle 1 Day 1\n  * Chemotherapy \\\u003C 14 days prior to planned Cycle 1 Day 1, or \\\u003C 42 days for mitomycin or nitrosoureas\n  * Targeted small molecule therapy \\\u003C 14 days prior to planned Cycle 1 Day 1\n  * Receipt of experimental therapy within 21 days or 5 experimental treatment half-lives (whichever is longer) prior to planned Cycle 1 Day 1\n  * Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started \\\u003C 14 days prior to planned Cycle 1 Day 1 are not permitted. Hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started ≥ 14 days prior to planned Cycle 1 Day 1\n  * Radiotherapy within 2 weeks prior to planned Cycle 1 Day 1 and the radiation is not administered to a target lesion\n  * Any prior allogeneic tissue\u002Fsolid organ transplantation, including allogeneic hematopoietic stem cell transplantation. Individuals with a history of autologous hematopoietic stem cell transplantation are also excluded\n* Have not recovered (ie, Grade 1 or lower) from AEs due to a previously administered agent\n* Prior treatment with approved or experimental prohibited agents as detailed in the protocol.\n* Diagnosis of immunodeficiency, either primary or acquired, or requires systemic corticosteroids (\\> 10 mg of prednisone daily, or equivalent). However, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted\n* Have an active second malignancy\n* Have known active central nervous system (CNS) metastases\n* Individuals with carcinomatous meningitis or primary CNS tumors are excluded regardless of clinical stability\n* Meet any of the following criteria for cardiac disease:\n\n  * Myocardial infarction or unstable angina pectoris within 6 months of enrollment\n  * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication)\n  * QT interval \\> 470 msec\n  * New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction less than 40%\n* Meet any of the following infectious criteria:\n\n  * Have active serious infection requiring antimicrobials\n  * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV. In individuals with a history of HBV or HCV, individuals with detectable viral loads will be excluded\n  * Individuals who test positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody are eligible with a negative HBV DNA by quantitative Polymerase chain reaction (PCR)\n  * Individuals who test positive for HCV antibody. Individuals who test positive for HCV antibody are eligible with a negative HCV RNA by quantitative PCR\n  * Individuals who test positive for HIV antibody\n* History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or radiation pneumonitis requiring steroids\n* Symptomatic ascites or pleural effusion\n* Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations\n* Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the individuals participation in the study\n* Use of any live vaccines against infectious diseases within 4 weeks (28 days) of initiation of study drug(s) (inactivated, viral vector vaccines, and messenger RNA (mRNA) vaccines are allowed; seasonal vaccines should be up to date prior to planned Cycle 1 Day 1)\n* Parts C (Dose Escalation) and D (Dose Expansion): Combination Cohorts:\n\n  * Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months prior to planned Cycle 1 Day 1\n  * Individuals who previously received topoisomerase 1 inhibitors or antibody-drug conjugates containing a topoisomerase 1 inhibitor\n  * Known severe intolerance or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous (IV) immunoglobulin preparations; any history of anaphylaxis; history of human anti-human antibody response\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":503,"type":21},278,[24],"The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors.\n\nThe primary objectives of this study are to:\n\n* To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors\n* To identify the maximum tolerated dose (MTD) and\u002For the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and\u002For the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors",[28],{"date":247,"type":40},{"date":509,"type":40},"2024-01-09",{"date":448,"type":21},{"name":512,"class":47},"Gilead Sciences",8,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":522,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":543},"100460214","phase-1-tt-702-in-patients-with-advanced-solid-tumours-100460214","NCT05272709","TT-702 in Patients With Advanced Solid Tumours.","CURATE: A Cancer Research UK Phase I\u002FII, Dose Escalation and Expansion Trial of TT-702, A Selective Adenosine A2BR Antagonist, Given Orally as a Monotherapy Agent and in Combination, in Patients With Advanced Solid Tumours","CURATE","Inclusion criteria:\n\n1. Be able to provide informed consent and be capable of co-operating with IMP administration, procedures and follow-up.\n2. Be willing to provide samples (blood and tissue) as required.\n3. Consent to access any available archival tissue.\n4. Consent for fresh tumour biopsy samples at baseline and on trial (may be Investigator mandated for patients in the dose escalation phase. Investigators will consider whether a biopsy is feasible for the patient in the dose escalation phase and this will not impede participation in the trial if biopsy is not a suitable option.\n5. Life expectancy estimated by the Investigator to be at least 12 weeks.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. Aged 16 years or over at the time consent is given.\n8. Haematological and biochemical indices within the protocol specified ranges.\n9. Objectively or measurable evaluable disease, radiologically according to RECIST Version 1.1 (and\u002For, in mCRPC patients, according to PCWG3 criteria). Has radiological disease progression (and\u002For, in mCRPC patients, PSA progression according to PCWG3 criteria) at the time of trial enrolment.\n10. Castrate levels of testosterone (\\\u003C1.7 nmol\u002FL \\[50 ng\u002FdL\\]) (mCRPC patients only).\n11. Phase I, dose escalation phase\n\n    Histologically or cytologically proven advanced solid tumours refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator or is declined by the patient. Phase I dose escalation cohorts are:\n    * Phase I, Cohort 1M (TT-702 monotherapy cohort):\n\n    MMRd tumour, confirmed by either:\n\n    i. Loss of MSH2, MSH6, MLH1, PMS2 by ICH (total or near total) OR ii. Loss of function mutation f MMR gene(s) AND iii. High tumour mutation burden (depends on assay but typically \\>15 mutations\u002FMB sequenced).\n\n    Non-MMRd tumours:\n\n    mCRPC: - Prior treatment with a next generation hormonal agent. - Adenocarcinoma without neuroendocrine or small cell features.\n\n    TNBC:\n\n    \\- Human epidermal growth factor receptor 2 negativity (negative immunohistochemistry \\[IHC\\] staining \\[score 0 or 1\\] or negative fluorescence in situ hybridisation based on the American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines and recommendations) and determined through local testing in NHS lab within UKAS\u002FISO 15198 scope of accreditation.\n    * ER and progesterone receptor negativity (\\\u003C1% positive staining cells in the invasive tumour) determined locally using IHC per American Society of Clinical Oncology\u002FCollege of American Pathologists criteria.\n    * Patients who have received prior anti-PD-1\u002Fanti-PD-L1 agent must have experienced Investigator-assessed initial clinical benefit from the most recent anti-PD-1\u002Fanti-PD-L1 treatment (either as monotherapy or in combination with other compounds) for at least 10 weeks, followed by subsequent progression. Initial benefit is defined as SD or better with an anti-PD-1\u002Fanti-PD-L1 therapy.\n\n    CRC, NSCLC and PDAC:\n\n    \\- Histologically or cytologically proven diagnosis of CRC, NSCLC or PDAC\n\n    • Phase I, Cohort 1P (TT-702 \\& PD-1\u002FPD-L1 combination cohort): Patients who have had prior treatment with an ICI.\n\n    Phase II (expansion phase)\n\n    Histologically or cytologically proven advanced solid tumour of particular interest based on preclinical and clinical data, refractory to conventional treatment or, for which no conventional therapy is considered appropriate by the Investigator or, is declined by the patient. Phase II expansion cohorts are:\n\n    Cohort 2M (TT-702 Monotherapy expansion cohort) and Cohort 2P (TT-702 \\& anti-PD-1\u002FPD-L1 combination cohort):\n    * Patients must have been previously treated with an ICI\n    * MMRd tumour, confirmed by either:\n\n      i. Loss of MSH2, MSH6, MLH1, PMS2 by IHC (total or near total) OR ii. Loss of function mutation of MMR gene(s) AND iii. High tumour mutation burden (depends on assay but typically \\>15 mutations\u002FMB sequenced).\n\n    Exclusion criteria:\n\n\u003C!-- -->\n\n1. Radiotherapy (except single fractions for palliative reasons), endocrine therapy during the previous four weeks, immunotherapy and chemotherapy during the previous four weeks(previous six weeks for nitrosoureas, Mitomycin-C) before receiving TT-702. A washout period of eight weeks is required for enzalutamide and apalutamide before the patient receives their first dose of TT-702. A washout period of 4 weeks or 5 half-lives whichever is shorter for any other previous preceding IMPs is required before the patient receives their first dose of TT-702 (no washout is needed from ICI).\n2. Patients with ongoing toxic manifestations of previous treatments greater than NCI CTCAE Version 5.0 Grade 1. Exceptions to this are alopecia and any ongoing toxic manifestation which in the opinion of the Investigator should not exclude the patient.\n3. Patients with symptomatic brain or leptomeningeal metastases should be excluded. Asymptomatic patients with previously treated and stable brain metastases (in previous four weeks to trial entry) and not requiring any steroids are eligible for the trial. Patients who are stable on anticonvulsants are also eligible.\n4. Women of childbearing potential (or are already pregnant or lactating). However, those patients who meet the following points are considered eligible:\n\n   • Have a negative highly sensitive pregnancy test of a serum sample within 7 days prior to trial inclusion; and\n\n   • Agree to use two forms of medically approved contraception: i. one highly effective form including but not limited to: oral, injected,implanted, transdermal or intravaginal hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormonereleasing system, bilateral tubal occlusion or vasectomised partner; ii. plus a barrier method (for example, condom plus spermicide); iii. or agree to sexual abstinence. Effective from the first administration of TT-702, throughout the trial and for six months after the last administration of IMP.\n5. Male patients with partners of childbearing potential. However, those patients who meet the following points are considered eligible:\n\n   • Agree to take measures not to father children by using a barrier method of contraception \\[condom plus spermicide\\] or sexual abstinence effective from the first administration of IMP throughout the trial and for six months after the last administration of IMP.\n\n   • Male patients with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicide) to prevent exposure of the foetus or neonate.\n   * Non-vasectomised male patients must also be willing to ensure that any partner of childbearing potential uses a highly effective method of contraception (for example, oral, injected, implanted, transdermal or intravaginal hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system or bilateral tubal occlusion) or agree to sexual abstinence for the same duration.\n6. Major thoracic or abdominal surgery from which the patient has not yet recovered.\n7. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. Patients with previous Hepatitis C exposure but no current infection are eligible to participate.\n8. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV).\n9. Prior bone marrow transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks.\n10. Concurrent congestive heart failure, prior history of class II-IV cardiac disease (New York Heart Association \\[NYHA\\]), prior history of clinically significant cardiac ischaemia or prior history of clinically significant cardiac arrhythmia. Patients with significant cardiovascular disease are excluded as defined by:\n\n    a. History of congestive heart failure requiring therapy (NYHA III or IV); b. History of unstable angina pectoris or myocardial infarction up to six months prior to trial entry (patients with previous cardiac or thrombotic events who are now stable and or recovered are eligible); c. Presence of severe valvular heart disease; d. Presence of a ventricular arrhythmia requiring treatment; e. Left ventricular ejection fraction \\\u003C 50%; f. Has a QTcF prolongation to \\>470 milliseconds (ms) based on a 12-lead ECG in triplicate; g. Previous stroke or transient ischaemic attack within 6 months of trial entry; h. History of clinically significant peripheral vascular disease\u002Fvasculitis\u002Fvasculopathy.\n11. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I\u002FII trial of TT-702. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator would be acceptable.\n12. Previous malignancies of other types, apart from adequately treated in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years or more and are deemed at negligible risk for recurrence, are eligible for the trial.\n13. A concomitant significant other illness that might in the opinion of the Investigator affect compliance with the protocol or interpretation of results, examples include but are not limited to autoimmune diseases or immune deficiency, or other disease with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar\u002Fplantar fibromatosis), alcoholic hepatitis, cirrhosis, and inherited liver disease, previous organ transplantation, uncontrolled or poorly controlled diabetes mellitus (for example HbA1c \\>10%) and patients with non-alcoholic steatohepatitis.\n14. History of an immune-mediated adverse event of Grade 3 or above attributed to prior cancer immunotherapy that resulted in permanent discontinuation of the prior immunotherapeutic agent. Immune-mediated adverse events related to prior immunomodulatory therapy (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not either resolved completely to baseline or are Grade ≤2 in severity.\n15. Patients on systemic corticosteroids (apart from replacement doses for endocrinopathy up to an equivalent of 10 mg QD prednisolone). Topical or inhaled steroids for pre-existent diseases are allowed.\n16. Patients who received a live vaccine within 30 days before trial enrolment are excluded.\n17. Patients with a known or suspected history of hypersensitivity or allergy to TT-702, or any of its excipients (for any strength) are excluded:\n\n    • TT-702 10 mg strength, excipients: hydroxypropyl cellulose, sodium lauryl sulfate, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate;\n\n    • TT-702 40 mg strength, excipients: hydroxypropyl cellulose, sodium lauryl sulfate, mannitol, croscarmellose sodium and magnesium stearate;\n    * TT-702 120 mg strength, excipients: poloxamer-188, sodium lauryl sulfate, mannitol, croscarmellose sodium and magnesium stearate in hydroxypropyl methylcellulose (HPMC) capsules;\n    * TT-478 (also known as GS-6201 or CVT-6883).\n18. Patients who take therapies that inhibit or induce CYP3A must be excluded.\n19. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.\n\nIf a patient is taking any dietary supplements or complementary medicines\u002Fbotanicals, the Sponsor's Centre for Drug Development (CDD) must be informed at the earliest opportunity both prior to enrolment and during the patient's time on trial.","16 Years",{"count":83,"type":21},[24,25],"This clinical trial is evaluating the drug candidate TT-702 in patients with advanced solid tumours. The main aims of the trial are to determine the maximum dose of TT-702 that can be given safely to patients alone and in combination with other anti-cancer agents.",[28],[528,529,530,531,150,532,533,294],"Adenosine receptors","MSI Deficient Cancers","MMR Deficient Cancer","Castrate resistant Prostate Cancer","Pancreatic Ductal Adenocarcinoma","Non-Small Cell Lung Cancer","2026-08-10",{"date":324,"type":40},{"date":537,"type":40},"2022-01-19",{"date":539,"type":21},"2028-04",{"name":541,"class":542},"Cancer Research UK","OTHER",3,{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":557,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":572},"100605353","a-study-to-investigate-the-pharmacokinetics-and-safety-of-subcutaneous-rilvegostomig-in-adult-participants-with-advanced-solid-tumors-previously-treated-with-standard-of-care-therapy-100605353","NCT07161414","A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy","A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics, and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (ARTEMIDE-subQ)","ARTEMIDE-subQ","Inclusion Criteria:\n\n* Histologically or cytologically documented advanced (metastatic and\u002For unresectable) solid tumor.\n* Participants must have received prior anticancer treatment for the disease under study.\n* IO monotherapy deemed appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment with no deterioration.\n* Minimum life expectancy of ≥ 12 weeks at enrollment.\n* Adequate organ and marrow function.\n* Body weight ≥ 30 kg.\n\nExclusion Criteria:\n\n* Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.\n* History of organ transplant.\n* History of another primary malignancy that was active within past 2 years.\n* Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.\n* Unstable, symptomatic brain metastasis or spinal cord compression.\n* History of leptomeningeal carcinomatosis.\n* Active primary immunodeficiency\u002Factive infectious disease including tuberculosis (TB), human immunodeficiency virus (HIV) infection or hepatitis A, B or C infection.\n* History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure, history of myocardial infarction within the past 6 months.\n* Uncontrolled intercurrent illness including but not limited to ongoing or active known infection; interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea; active non-infectious skin disease requiring systemic treatment.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* Known allergy or hypersensitivity to rilvegostomig, hyaluronidase, or any excipients of the investigational products.\n* Participants experienced a toxicity to prior immunotherapy that led to permanent discontinuation of prior immunotherapy.\n* Prior anticancer treatment, including immunotherapy, up to 28 days prior to the first dose of study treatment.",{"count":553,"type":21},40,[24],"The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.",[28],[558,559,560,561,562,563],"Recombinant Human Hyaluronidase","Immunooncology monotherapy","T cell Immunoglobulin and Immunoreceptor Tyrosine-based Inhibitory Motif Domain (TIGIT)","Programmed Cell Death Protein 1 (PD-1)","Bispecific immunotherapy","Checkpoint inhibitor","2026-08-07",{"date":534,"type":40},{"date":567,"type":40},"2025-11-25",{"date":569,"type":21},"2029-07-24",{"name":571,"class":47},"AstraZeneca",11,{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":22,"phases":582,"briefSummary":583,"conditions":584,"keywords":585,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":451},"100583762","a-study-of-mrna-4106-or-mrna-4200-administered-alone-or-in-combination-with-anti-cancer-agents-in-participants-with-solid-tumors-100583762","NCT06880549","A Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors","A Phase 1, Open-label, Multicenter, Dose-escalation Study of mRNA-4106 or mRNA-4200 Administered Alone or in Combination With Anti-Cancer Agents in Participants With Solid Tumors","Key Inclusion Criteria:\n\n* Arm 1: Histologically confirmed advanced or metastatic cancer (melanoma, non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal carcinoma, head and neck squamous cell carcinoma (HNSCC), urinary bladder cancer (UBC), colon\u002Frectal adenocarcinomas, gastric, ovarian, cervical, and endometrial carcinomas) with measurable disease as determined by Response Evaluation Criteria In Solid Tumors volume 1.1 (RECIST v1.1) and have completed or refused all standard therapies (no limit to prior lines of therapy). Participants must have a tumor lesion amenable to biopsy, or alternatively archival tumor tissue is acceptable as long as the collection date is within one year of the enrollment date.\n* Arm 2: Histologically confirmed advanced or metastatic cancer (melanoma, NSCLC, esophageal carcinoma, HNSCC, urothelial\u002Fbladder carcinoma, gastric, colon\u002Frectal adenocarcinomas, ovarian, cervical, and endometrial carcinomas \\[Note: HCC not included\\]) with measurable disease as determined by RECIST v1.1 and have completed or refused all standard therapies (no more than 5 prior lines of therapy). Participants must have a tumor lesion amenable to biopsy, or alternatively archival tumor tissue is acceptable if no intervening systemic therapy was received.\n* Arm 2: Participant life expectancy of ≥90 days.\n* Arm 1 and Arm 2: Participant has an Eastern Cooperative Oncology Group performance status of ≤1.\n* Arm 1 and Arm 2: Participant has adequate hematological and biological function.\n* Arm 1 and Arm 2: Participants who could become pregnant: negative pregnancy test within 24 hours before the first dose of study treatment.\n\nKey Exclusion Criteria:\n\n* Arm 1 and Arm 2: Participant has active central nervous system tumors or metastases\n* Arm 1 and Arm 2: Participant has received treatment with prohibited medications\u002Ftreatments (that is, concurrent anticancer therapy including other chemotherapy, hormonal anticancer therapy, biologic therapy, or immunotherapy) or investigational agents within 5 half-lives or 14 days prior to the first day of study treatment (Cycle 1 Day 1), whichever is shorter.\n* Arm 1 and Arm 2: Participant has required the use of immunosuppressive doses of systemic steroids or absorbed topical steroids (doses \\>10 milligrams \\[mg\\] prednisone daily equivalent) within 2 weeks before study treatment administration or currently requiring maintenance doses of \\>10 mg prednisone or equivalent per day.\n* Arm 1 and Arm 2: Participant has any plan to receive a live attenuated vaccine during study treatment or has received a live vaccine within 30 days before the first dose of study treatment.\n* Arm 1 and Arm 2: Participant has reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline. Any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and prespecified laboratory values.\n* Arm 1 and Arm 2: Participant has any unstable or clinically significant concurrent medical\u002Fpsychiatric illness or social situation that would limit compliance with study requirements or compromise the ability of the participant to provide written informed consent, per the discretion of the Investigator.\n* Arm 1 and Arm 2: Participant has concurrent enrollment in another clinical study (unless it is an observational noninterventional clinical study).\n\nNote: Other inclusion and exclusion criteria may apply.",{"count":581,"type":21},42,[24],"The purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.",[28],[586,587,588,589,590,591,592],"Locally advanced","Metastatic","Relapsed or refractory solid tumor malignancies","Pembrolizumab","Oncology","Melanoma","Solid tumors",{"date":534,"type":40},{"date":595,"type":40},"2025-03-25",{"date":597,"type":21},"2027-08-03",{"name":599,"class":47},"ModernaTX, Inc.",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":624,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":658},"100484789","phase-1-a-study-of-a-selective-t-cell-receptor-tcr-targeting-bifunctional-antibody-fusion-molecule-star0602-in-participants-with-advanced-solid-tumors-100484789","NCT05592626","A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human, Open-Label, Dose Escalation and Expansion Study of STAR0602, a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule, in Subjects With Unresectable, Locally Advanced, or Metastatic Solid Tumors That Are Antigen-rich (START-001)","START-001","Inclusion Criteria:\n\n1. Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Participants should not have received more than three regimens of prior therapies for their advanced or metastatic diseases. For Phase 2 Cohorts 8 and 10 (see below), participants should not have received more than one line of prior therapy.\n2. For Phase 1, participants must have one of the following solid tumors:\n\n   1. High mutational burden (TMB-H)\n   2. Microsatellite Instability (MSI-H)\u002FDNA mismatch repair (dMMR)\n   3. Virally associated tumors\n   4. Solid tumors generally considered as immunogenic (e.g., melanoma and renal cell carcinoma) are eligible without prior testing for TMB, MSI or viral status after the Sponsor's approval.\n3. For Phase 2, participants must have one of the following solid tumors:\n\n   1. TMB-H (not enrolling)\n   2. MSI-H\u002FdMMR (not enrolling)\n   3. CRC (both Ras wild type and mutant) (not enrolling)\n   4. NSCLC (recurrent or Primary Stage 4)\n   5. CRC with pMMR\u002FMSS (without TMB-H requirement)\n\n   (Other tumor histologies may also be included in Phase 2 as additional data emerge to support their inclusion.)\n4. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:\n\n   * No concurrent treatment for CNS disease (e.g., surgery, radiation, corticosteroids \\> 10 mg prednisone\u002Fday or equivalent);\n   * No concurrent leptomeningeal disease or cord compression.\n5. Subjects who have previously received a CPI (e.g., anti-PD-L1, anti-PD-1, anti CTLA 4) prior to enrollment must have CPI immune-related toxicity resolved to either Grade ≤ 1 or baseline (prior to the CPI) to be eligible for enrollment.\n\n   * Subjects who experienced previous CPI-related endocrine abnormalities are eligible for the study regardless of CTCAE grade if well controlled on replacement therapy.\n   * Subjects who have had previous CPI-related Grade 3 to 4 pneumonitis, peri\u002Fmyocarditis, colitis and bowel perforation, myositis, encephalitis, or peripheral neuropathy will need Sponsor approval.\n\nExclusion Criteria:\n\n1. Participants with a history of known autoimmune disease with exceptions of:\n\n   * Vitiligo;\n   * Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;\n   * History of Graves' disease, now euthyroid for \\> 4 weeks;\n   * Hypothyroidism managed by thyroid replacement;\n   * Alopecia;\n   * Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs.\n   * Adrenal insufficiency well controlled on replacement therapy.\n2. Major surgery or traumatic injury within 8 weeks before first dose of study drug.\n3. Unhealed wounds from surgery or injury.\n4. Treatment with \\>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study drug. Exceptions may be made for patients who have had allergic reaction to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed.\n5. Prior therapy within the following timeframe before planned infusion of STAR0602 as follows:\n\n   * Cytotoxic chemotherapy, small molecule inhibitors, radiation, interventional radiology procedure, or similar investigational therapies within ≤ 2 weeks or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to a previously administered agent;\n   * Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar investigational therapies within 6 weeks prior to the initiation of study drug or participants who have not recovered (i.e., ≤ Grade 1 or to baseline) from AEs due to agents administered more than 4 weeks earlier. Note: Participants with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception to this criterion and may qualify for the study.\n6. Clinically significant cardiovascular\u002Fvascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises\n7. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study drug.\n8. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.\n9. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.\n10. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas.\n11. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation).\n12. Hepatic metastases unless adequately treated, either locally (e.g., by surgery, radiofrequency ablation, or chemoembolization) or systemically or both, and stable for 3 months.\n13. Bulky disease defined as any lesion ≥ 5 cm in greatest dimension unless approved by the Sponsor.",{"count":609,"type":21},366,[24,25],"This is an open label, multicenter, phase 1\u002F2 study to assess the safety\u002Ftolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants with advanced solid tumors that are antigen-rich.",[28,613,614,615,616,617,618,619,620,621,622,623,272,294],"Genital Neoplasm, Female","Urogenital Neoplasms","Lung Neoplasm","Neoplasms by Site","Papillomavirus Infection","Epstein-Barr Virus Infections","Carcinoma","Neoplasms","Vulvar Neoplasms","Vulvar Diseases","Abdominal Neoplasm",[28,625,626,627,628,629,630,631,632,633,634,635,636,370,637,638,639,640,591,641,642,643,464,294,644,645,646,647,648,649],"STAR0602","Intravenous","Antineoplastic Agents","T Cell Receptor-targeting","Bifunctional Antibody-Fusion","Specific T Cell Activator","Tumor Mutational Burden (TMB) High","Microsatellite Instability (MSI) High","Virally Associated Malignancies","Checkpoint Inhibitor Resistance","Immunotherapy","Immune Checkpoint Inhibitor Resistance","Nasopharyngeal Cancer","Non-small Cell Lung Cancer","Small Cell Lung Cancer","Biliary Cancer","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Skin Basal Cell Carcinoma","Small Bowel Cancer","Cervical Cancer","Gastrointestinal Neoplasms","Gastric Cancer","Esophageal Cancer","Bladder Cancer","2026-08-06",{"date":394,"type":40},{"date":653,"type":40},"2023-01-04",{"date":655,"type":21},"2027-09",{"name":657,"class":47},"Marengo Therapeutics, Inc.",19,{"id":660,"slug":661,"hasResults":12,"nctId":662,"briefTitle":663,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":666,"targetDuration":4,"studyType":22,"phases":668,"briefSummary":669,"conditions":670,"keywords":675,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":687},"100602773","phase-1-a-study-of-phn-012-in-patients-with-advanced-solid-tumors-100602773","NCT07127874","A Study of PHN-012 in Patients With Advanced Solid Tumors","First-in-Human, Phase 1 Study of PHN-012, an Antibody Drug Conjugate, in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Has histologically confirmed, advanced\u002Fmetastatic:\n\n  1. Colorectal adenocarcinoma (CRC), or\n  2. Non-small cell lung cancer (NSCLC), or\n  3. Pancreatic ductal adenocarcinoma (PDAC).\n* Has received at least one prior systemic therapy and radiologically or clinically determined progressive disease during or after the most recent line of therapy, and for whom no further standard therapy is available or who is intolerant to standard therapy.\n* Has measurable disease.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has adequate organ function.\n* Has available tumor tissue sample at screening (either an archival specimen or fresh biopsy material).\n\nExclusion Criteria:\n\n* Had prior treatment with any ADC containing topoisomerase-1 inhibiting payload.\n* Has unstable central nervous system metastasis.\n* Has persistent toxicities from previous systemic anti-cancer treatments of Grade \\>1.\n* Has received systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the study drug.\n* Has received wide-field radiotherapy (\\> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of the study drug, or no recovery from side effects of such intervention.\n* Had major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the study drug, or no recovery from side effects of such intervention.\n* Has a history of non-infectious pneumonitis (NIP) \u002F interstitial lung disease (ILD) requiring systemic steroids within 6 months prior to first dose of the study drug, active NIP \u002F ILD or suspected NIP \u002F ILD which cannot be ruled out by imaging for Screening.",{"count":667,"type":21},165,[24],"This first-in-human study will evaluate safety, tolerability, anti-tumor activity, immunogenicity, pharmacokinetics and pharmacodynamics of PHN-012, a novel antibody-drug conjugate (ADC), in patients with advanced solid tumors.",[671,672,673,674,28],"Colon Cancer","Pancreatic Cancer","Lung Cancer (NSCLC)","Advanced Cancer",[676,619,677,678],"Antibody Drug Conjugate","Cancer","Solid Tumor","2026-08-05",{"date":650,"type":40},{"date":682,"type":40},"2025-09-23",{"date":684,"type":21},"2028-05",{"name":686,"class":47},"Pheon Therapeutics",26]