[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,291,0,25,[9,45,90,114,140,159,194,242,264,284,304,330,358,384,418,439,504,526,579,605,629,657,675,698,719],{"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":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100498099","phase-1-a-study-of-ds-1103a-combination-therapy-in-participants-with-advanced-solid-tumors-100498099",false,"NCT05765851","A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors","A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures\n* Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old)\n* Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic\n* Is willing and able to provide tumor tissue\n* Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment\n* Has adequate organ and bone marrow function within 14 days before the start of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to Cycle 1 Day 1.\n* A woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant as confirmed by highly sensitive pregnancy test and agrees to adhere to a contraceptive method that is highly effective during the Treatment Period and for at least the time needed to eliminate each study drug after the last dose.\n* A male participant capable of producing sperm is eligible to participate if he agrees to adhere to the contraception methods as specified in the protocol and avoids donating sperm during the Treatment Period and for at least the time needed to eliminate each study drug.\n* Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions\n\nDose-escalation Phase:\n\n* Has progressed or was non-responsive to available therapies and for which no standard or available anticancer therapy exists\n* Has a pathologically documented HER2-expressing or HER2-mutated solid tumor\n\nDose-expansion Phase:\n\n* Has pathologically documented specific HER2 altered advanced solid tumor type\n* Has received prior therapy as specified in the protocol\n\nExclusion Criteria:\n\n* Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.\n* Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol\n* Medical history of myocardial infarction (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV\n* Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Has a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products or other monoclonal antibodies\n* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals\n* Is requiring concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications during the study\n* Has received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s)\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and CD4 count.\n* Has active or uncontrolled HBV or HCV. Hepatitis B and C screening testing is required. Participants are eligible only if they meet criteria as specified in the protocol.\n* Has unresolved toxicities from previous anticancer therapy\n* Female who is pregnant, breastfeeding, or planning to become pregnant\n* Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder\n* Any autoimmune, connective tissue or inflammatory disorders\n* Prior complete pneumonectomy\n* Any of the following within 6 months of enrollment: Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolism event\n* Psychological, social, familial, or geographical factors that would prevent regular follow-up\n* Any active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy\n* Uncontrolled hypertension (resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) and\u002For severe arrhythmia within 28 days before enrollment","ALL","18 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.",[27],"Advanced Solid Tumor",[27,29,30,31],"DS-1103a","CD47","SIRPa","RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":36},"2023-05-30",{"date":40,"type":21},"2030-05-15",{"name":42,"class":43},"Daiichi Sankyo","INDUSTRY",11,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":71,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100529338","a-study-of-her3-dxd-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-100529338","NCT06172478","A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors","HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Sign and date the informed consent form prior to the start of any study-specific qualification procedures. A separate tissue screening consent will be obtained from all subjects to meet the baseline tumor tissue requirement.\n2. Participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n3. Has locally advanced unresectable or metastatic disease (not curable by surgery or radiation) as follows:\n\n   Cutaneous (acral and non-acral) melanoma\n   1. Histologically or cytologically confirmed cutaneous (acral or non-acral) melanoma\n   2. Disease progression while on or after having received treatment with ≥1 prior line of anti-programmed cell death protein (PD-1) or anti-programmed death-ligand 1 (PD-L1) based therapy (previous use of other immune checkpoint inhibitors \\[ICIs\\] \\[ie, anti-CTLA4, anti- LAG-3\\] is acceptable). Prior anti-PD-(L)1 therapy in the adjuvant setting is allowed if there is recurrence within 12 weeks of the last dose. If the participant had BRAFm melanoma, they must have had disease progression on BRAF\u002FMEK inhibitor therapy as well.\n\n      Squamous cell carcinomas of the head and neck\n   3. Squamous cell carcinoma of the head and neck (with a primary location of oral cavity,oropharynx, larynx, hypopharynx) that is human papillomavirus (HPV) positive or negative (as determined by local standard). Excludes tumor location in the nasopharynx, nasal cavity, paranasal sinuses, and unknown primary locations.\n   4. Disease progression after having received treatment with ≥1 and \\\u003C3 prior lines of systemic therapy in the unresectable recurrent or metastatic setting.\n\n      Must have had disease progression on anti-PD-(L)1 (either as monotherapy or in combination with chemotherapy or other therapies). Must also have had disease progression on a platinum-based chemotherapy (PBC) regimen either in the recurrent or metastatic setting or in the locally advanced setting with curative intent.\n\n      Gastric or GEJ adenocarcinoma\n   5. Tumor tissue must be confirmed as negative for HER2 expression (immunohistochemistry \\[IHC\\] 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   6. Disease progression after having received treatment with ≥2 prior lines of therapy that include PBC with or without anti-PD-1 therapy.\n\n      Ovarian Carcinoma\n   7. Pathologically documented high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.\n   8. Documented disease progression ≥4 weeks after the last dose of PBC and \\\u003C6 months of last dose of PBC in the advanced or metastatic setting. Prior use of folate reductase alpha targeting antibody-drug conjugate (ADC) (ie, mirvetuximab soravtansine) is allowed.\n\n      Cervical Cancer\n   9. Pathologically or cytologically documented recurrent or persistent squamous, adenosquamous, or adenocarcinoma of the uterine cervix.\n   10. Disease progression after having received ≥1 line of systemic therapy in the recurrent or metastatic setting. This may include prior anti-PD-(L)1 treatment and\u002For tissue factor directed ADC (tisotumab vedotin \\[TV\\]) per regional standard of care.\n\n       Endometrial Cancer\n   11. Pathologically or cytologically documented endometrial cancer (carcinoma of any histological sub-type or endometrial carcinosarcoma), irrespective of microsatellite instability (MSI) or mismatch repair (MMR) status.\n   12. Documented disease progression after having received ≥1 prior line of therapy (maximum of 3) PBC containing systemic treatment and an anti-PD(L)-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Bladder Cancer\n   13. Pathologically or cytologically documented locally advanced\u002Funresectable or metastatic urothelial carcinoma of the bladder, renal pelvis, ureter, or urethra. Histological variants are allowed if urothelial histology is predominant. Small cell\u002Fneuroendocrine tumors are not allowed even if mixed histology.\n   14. Relapsed or progressed after treatment with ≥1 prior line of therapy (maximum of 3) that contains anti-PD-(L)1 therapy in the perioperative or metastatic setting. At least 1 line of therapy must also contain one of the following treatment modalities: chemotherapy or enfortumab vedotin. Prior fibroblast growth factor receptor (FGFR)-inhibitor treatment for those who are eligible are allowed.\n\n       * Required treatments can be given in combination or sequentially\n       * Prior cisplatin-based therapy or PD-(L)1 inhibitor therapy given for the treatment of muscle invasive urothelial carcinoma is counted as 1 line of therapy\n       * The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy\n       * Participants in the second-line setting who have previously received enfortumab vedotin and pembrolizumab in combination can be enrolled.\n\n       Esophageal Carcinoma\n   15. Pathologically or cytologically documented esophageal squamous cell carcinoma.\n   16. Must have documented disease progression after having received 2 prior lines of therapy including previous PBC with or without an anti-PD-1 therapy-containing regimen (combined or sequential) in the advanced\u002Fmetastatic setting.\n\n       Pancreatic Carcinoma\n   17. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma.\n   18. Relapsed or disease progression after having received 1 prior line of systemic therapy in the locally advanced\u002Fmetastatic setting.\n\n       Prostate Cancer\n   19. Pathologically or cytologically documented unresectable locally advanced or metastatic castration-resistant prostate cancer (CRPC).\n   20. Adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.\n   21. Surgically or medically castrated, with testosterone levels of \\\u003C50 ng\u002FdL.\n   22. Documented objective progression as determined by radiographic progression for subjects with measurable disease after androgen deprivation.\n   23. Relapsed or disease progression after having received treatment with ≥1 of the following novel hormonal agents: abiraterone, enzalutamide, apalutamide, or darolutamide.\n   24. Relapsed or disease progression after having received ≥1 cytotoxic chemotherapy regimen that included a taxane.\n\n       Gastric Cancer 2L\n   25. Must have had gastric or GEJ adenocarcinoma confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC 2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n   26. Disease progression after having received treatment with only 1 prior line of systemic anti-cancer therapy that includes 5-FU-based chemotherapy with or without an anti-PD-1 therapy. For subjects whose tumors are claudin (CLDN) 18.2 positive, treatment with 5-FU based chemotherapy with CLDN18.2 directed therapy in the first-line setting is allowed.\n\n   Non-small Cell Lung Cancer aa. Histologically or cytologically documented metastatic or locally advanced nonsquamous NSCLC not amenable to curative surgery or radiation bb. Documentation of absence of actionable driver mutation (ie, ALK rearrangement, BRAF V600E mutation, EGFR-activating mutations \\[exon 19 deletion or L858R mutation\\], EGFR exon 20 insertion mutation, HER2 mutation, KRAS G12C mutation, MET exon 14 skipping mutation, NTRK 1\u002F2\u002F3 gene fusion, RET rearrangement, or ROS1 rearrangement). New testing for these genomic alterations is not required for Screening.\n\n   cc. Relapsed or disease progression after receiving only anti-PD-(L)1 and PBC (ie, platinum doublet) administered in combination or sequentially for metastatic disease.\n\n   Breast Cancer dd. Pathologically documented breast cancer that is assessed as HER2 negative (IHC2+\u002FISH-, IHC1+, or IHC0 per ASCO\u002FCAP guidelines), and HR positive (either ER and\u002For PgR positive \\[ER or PgR ≥1%\\] per ASCO\u002FCAP guidelines). The HER2 and HR results must be from a tumor sample obtained in the metastatic setting.\n\n   ee. Participant must have received one line of chemotherapy for mBC, but not more than one line and must have a clinically or radiologically documented evidence of tumor progression on or after CDK 4\u002F6 inhibitor combined with endocrine therapy; previous treatments with phosphoinositide 3-kinase (PI3K) inhibitors, mammalian target of rapamycin (mTOR) inhibitors, protein kinase B (PKB) inhibitors also known as AKT-inhibitors and poly ADP ribose polymerase (PARP)-inhibitors are allowed.\n4. Has ≥1 measurable lesion on CT or MRI as per RECIST v1.1 by investigator assessment. Prostate cancer participants with bone only disease may be eligible.\n5. Provides a pretreatment tumor tissue sample that meets 1 of the following collection requirements:\n\n   1. Tumor biopsy from ≥1 lesion not previously irradiated and performed since progression with the most recent systemic cancer therapy regimen and prior to signature of the tissue ICF (ARCHIVAL PRETREATMENT sample).\n\n      OR\n   2. Newly obtained pretreatment tumor biopsy from ≥1 lesion not previously irradiated and amenable to sampling, after signature of tissue ICF (FRESH PRETREATMENT sample)\n6. Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at screening.\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Has HER2-positive gastric cancer as classified by ASCO-CAP guidelines and determined prior to enrollment by assessment in a local laboratory that is Clinical Laboratory Improvement Amendments certified (US sites) or accredited based on specific country regulations.\n2. Has nasopharyngeal cancer.\n3. Has mucosal or uveal melanoma.\n4. Has a history of (non-infectious) interstitial lung disease (ILD), that required corticosteroids, has current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n5. Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses\n6. Is receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone daily or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1 Day 1.\n\n   Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.\n7. Had prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan).\n8. Has history of other active malignancy within 3 years prior to Cycle 1 Day 1, except the following:\n\n   1. Adequately treated nonmelanoma skin cancer\n   2. Adequately treated intraepithelial carcinoma of the cervix\n   3. Any other curatively treated in situ disease\n9. Has any evidence of severe or uncontrolled diseases (eg, active bleeding diatheses, active serious infection) psychiatric illness\u002Fsocial situations, geographical factors, substance abuse, or other factors that, in the investigator's opinion, make it high risk for the subject to participate in the study or that would jeopardize compliance with the protocol\n10. Has previously received topoisomerase-1 inhibitors (e.g., irinotecan) treatment in the advanced or metastatic disease setting.",{"count":53,"type":21},740,[55],"PHASE2","This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \\[cutaneous\u002Facral\\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.",[27,58,59,60,61,62,63,64,65,66,67,68,69,70],"Melanoma","Head and Neck Cancer","Gastric Cancer","Ovarian Carcinoma","Cervical Cancer","Endometrial Cancer","Bladder Cancer","Esophageal Cancer","Pancreatic Carcinoma","Prostate Cancer","Non-small Cell Lung Cancer (NSCLC)","Lung Cancer","Breast Cancer",[27,58,59,60,72,73,74,75,76,77,78,79,80,81,69,70],"Ovarian carcinoma","Cervical cancer","Endometrial cancer","Bladder cancer","Esophageal carcinoma","Pancreatic carcinoma","Prostate cancer","Patritumab Deruxtecan","HER3-DXd","U3-1402","2026-08-19",{"date":35,"type":36},{"date":85,"type":36},"2024-02-26",{"date":87,"type":21},"2028-10-10",{"name":42,"class":43},86,{"id":91,"slug":92,"hasResults":12,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100527940","phase-1-fih-xon7-in-advancedmetastatic-solid-tumors-100527940","NCT06154291","FIH XON7 in Advanced\u002FMetastatic Solid Tumors","Phase I\u002FII, Multi Center, Open Label, First-in-human, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, and Anti-tumors Efficacy of the Glyco-humanized Polyclonal Antibody XON7 in Patients With Advanced or Metastatic Solid Tumors","FIPO23","Inclusion Criteria:\n\n1. Provide signed, written informed consent.\n2. Male and female participant, age ≥ 18 years old (at the time consent is obtained)\n3. Solid tumors indications:\n\n   * Participant in phase I, must have a histologically or cytologically confirmed advanced or metastatic solid tumors for which no effective standard therapy is available. All tumor types except glioblastoma, could be included.\n   * Participant in phase II, must have histologically or cytologically confirmed advanced or metastatic solid tumors of the following: NSCLC, gastro-esophageal adenocarcinoma, CRC, pancreatic cancer, Sarcoma, TNBC, or ovarian cancer.\n4. Line of treatment: Participant must have solid tumors progressing after ≤ 4 lines of standard appropriate anticancer therapies for the specific tumor type, or for which the patient is ineligible. Participants whose cancers harbor molecular alterations for which targeted therapy is standard of care should have received health authority-approved appropriate targeted therapy for their tumor types before enrollment.\n5. Measurable disease per RECIST version 1.1 - v5\n6. (ECOG) performance status (PS) 0-1\n7. Life expectancy of at least 12 weeks.\n8. Adequate organ function\n9. QT duration corrected for heart rate by Fridericia's formula (QTcF) \\\u003C450 msec or QTcF \\\u003C480 msec for participants with bundle branch block.\n10. In France, a participant will be eligible for inclusion in this trial only if either affiliated to or a beneficiary of a social security category.\n11. Female participant who are not of child-bearing potential, and female participants of child-bearing potential who have a negative serum pregnancy test within 7 days prior to initial trial treatment. Female participants of child-bearing potential, and all male partners must consent to use a medically acceptable method of contraception throughout the trial period and for at least 60 days after the last dose of XON7. A barrier method of contraception must be included.\n12. Male participant willing to use adequate contraceptive measures throughout the trial period and for at least 60 days after the last dose of trial intervention.\n13. For phase II, participant in pharmacodynamics cohort must provide biopsy of a tumor lesion not previously irradiated during the screening period and must agree to provide at least one additional on-treatment biopsy between day 36 and 42 after trial intervention administration.\n14. For phase II, participant in pharmacodynamics cohort must have accessible tumor tissue available for fresh biopsy except for ovarian cancer and sarcoma.\n\nExclusion Criteria:\n\n1. A participant who has received more than 4 prior lines of therapy for advanced or metastatic disease.\n2. A participant who has had a prior anti-cancer mAb within 3 weeks prior to trial Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier prior to trial Day 1.\n3. A participant who has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial Day 1 or who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (Except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).\n4. A participant with ≥Grade 3 toxicity related to prior immunotherapy leading to treatment discontinuation.\n5. A participant whose toxicity related to prior treatment has not resolved to Grade 1 (except alopecia, hearing loss, grade 2 neuropathy or endocrinopathy managed with replacement therapy).\n6. A participant who has received major surgery 2 weeks before the first dose of trial treatment or has not recovered adequately from the toxicity and\u002For complications from any surgery (major or minor) before initiating trial treatment.\n7. Concomitant use of another experimental drug, or wash-out period of at least 5 half-lives for a previous experimental drug not completed before start of trial intervention\n8. Participant treated with drugs known to prolong the QT interval\n9. Participant with carcinomatous meningitis.\n10. Central nervous system (CNS) metastases, with the exception of individuals who have been previously treated CNS metastases, are asymptomatic, and have had no requirement for steroids for 3 weeks prior to first dose of trial drug.\n11. Malignancies other than disease under trial within 3 years prior to first dose of trial intervention.\n12. History of autoimmune disease\n13. Active or uncontrolled infections requiring systemic treatment (known human immunodeficiency virus infection, or positive test for hepatitis B surface antigen or hepatitis C).\n14. Any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation in the trial such as history or evidence of cardiovascular risk including any of the following:\n\n    * Recent (within the past 6 months) history of serious uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities including second degree (Type II) or third-degree atrioventricular block.\n    * Documented cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting, or bypass grafting within the past 6 months before enrollment.\n    * Documented congestive heart failure (Class II, III, or IV) as defined by the New York Heart Association functional classification system (NYHA, 1994).\n15. Prior allogeneic or autologous bone marrow transplantation or other solid organ transplantation.\n16. Current active liver or biliary disease (Except for Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per investigator assessment).\n17. Concurrent medical condition requiring the use of systemic immunosuppressive medications within 28 days before the first dose of trial treatment.\n18. Recent history (within the past 6 months) of acute diverticulitis, inflammatory bowel disease, intra-abdominal abscess, or gastrointestinal obstruction.\n19. Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia. Note: post-radiation changes in the lung related to prior radiotherapy and\u002For asymptomatic radiation-induced pneumonitis not requiring treatment may be permitted if agreed by the investigator and Medical Monitor.\n20. History of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n21. Recent history (within 6 months) of uncontrolled symptomatic ascites or pleural effusions.\n22. Participant who has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony- stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM- CSF\\], recombinant erythropoietin) within 2 weeks before the first dose of trial intervention.\n23. Known, current drug or alcohol abuse.\n24. Female participant who is pregnant or lactating.\n25. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n26. Inability or unwillingness to comply with trial and\u002For follow-up procedures outlined in the protocol.\n27. For France, patients under legal protection (safeguard, guardianship, curatorship)",{"count":99,"type":21},255,[24,55],"This is a two-stage trial consisting of a Part I, dose escalation and dose-finding component to establish the Maximal Tolerated Dose (MTD), if any, and Recommended Part 2 Dose (RP2D) of XON7, followed by a Part II component to investigate anti-tumors efficacy in selected solid tumor types and to further evaluate safety and tolerability of XON7 at RP2D.",[27,103],"Metastatic Cancer",[105],"Advanced or metastatic solid tumors",{"date":33,"type":36},{"date":108,"type":36},"2023-11-14",{"date":110,"type":21},"2027-11",{"name":112,"class":43},"Xenothera SAS",5,{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100610343","phase-1-a-study-of-bg-75098-alone-and-in-combination-with-other-agents-in-adults-with-advanced-solid-tumors-100610343","NCT07226349","A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors","A Phase 1a\u002F1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Participants must have measurable disease as assessed by RECIST v1.1.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Participants must have adequate organ function.\n* Dose Escalation Part A: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors potentially associated with cyclin-dependent kinase 2 (CDK2) dependency. Participants should have received prior treatment with available standard-of-care (SOC) systemic therapies for advanced\u002Fmetastatic disease, or for whom standard therapy is not available or not tolerated.\n* Dose Escalation Part B: Patients with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors who have received ≥ 1 prior line of systemic therapy in the metastatic setting.\n* Dose Expansion Cohort 1: Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable CDK4\u002F6 inhibitor-progressed solid tumors.\n* Dose Expansion Cohort 2: Participants with advanced solid tumors. Participants with primary platinum refractory disease are not eligible. Participants should have received ≥ 1 line of platinum-containing chemotherapy and ≤ 4 prior therapeutic regimens in the advanced\u002Fmetastatic setting.\n\nExclusion Criteria:\n\n* For all cohorts: Prior therapy selectively targeting CDK2 inhibition or degradation.\n* For combination cohorts: Prior therapy selectively targeting CDK4. Prior CDK4\u002F6 inhibitor standard of care therapy is permitted and required in local regions where it is approved and available.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":122,"type":21},105,[24],"The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with advanced solid tumors.",[27],[127,128,129,130],"Cyclin-Dependent Kinase 2- Targeted Protein Degrader","CDK2","CDK4","CDK4 inhibitor","2026-08-18",{"date":82,"type":36},{"date":134,"type":36},"2025-12-11",{"date":136,"type":21},"2028-11-01",{"name":138,"class":43},"BeOne Medicines",22,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":152,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":44},"100602806","phase-1-study-of-gs-5319-in-adults-with-solid-tumors-100602806","NCT07128303","Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors","A Phase 1 Study to Evaluate the Safety and Tolerability of GS-5319 Monotherapy and Combination Therapy in Adults With MTAP-deleted Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Participants diagnosed with histologically or cytologically confirmed solid tumor types who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy in the advanced setting (locally-advanced or metastatic).\n* Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient. Deoxyribonucleic acid (DNA) sequencing may be assessed locally such as by local next-generation sequencing (NGS) or by central laboratory assay when available.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n* Adequate organ function\n* Age ≥ 18yrs old ( ≥ 19 years old for patients in South Korea)\n* Participants must meet the following tissue requirements:\n\n  * pretreatment tumor tissue is required\n\nKey Exclusion Criteria:\n\n* Active second malignancy. Participants with a history of malignancy who have been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence may be enrolled.\n* Positive serum pregnancy test or participant who is breastfeeding.\n* Requirement for ongoing therapy with any prohibited medications.\n* Have not recovered (ie, returned to Grade 1 or baseline) from adverse events (AEs) due to a previously administered agent.\n* Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.\n* Ascites or pleural effusion that is symptomatic and\u002For requiring medical intervention.\n* Active human immunodeficiency virus (HIV)\u002Fhepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) infection\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":148,"type":21},476,[24],"The goal of this clinical study is to learn more about the study drug, GS-5319, its dosing, safety and tolerability when given as a single medication and as a combined medication in adults with solid tumors, where the participants show a specific gene alteration in the tumor. The gene helps produce methylthioadenosine phosphorylase (MTAP) enzyme. MTAP enzyme helps in normal growth of cells.\n\nThe primary objectives of the study are to assess the safety and tolerability of GS-5319 as monotherapy and combination therapy in participants with MTAP-deleted advanced solid tumors and identify the maximum tolerated dose (MTD)\u002Fmaximum administered dose (MAD) and\u002For the recommended dose(s) for expansion (RDE).",[27],{"date":82,"type":36},{"date":154,"type":36},"2025-08-28",{"date":156,"type":21},"2028-05",{"name":158,"class":43},"Gilead Sciences",{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":179,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":167,"type":21},399,[24],"This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[27,171,172,173,174,175,176,177,178],"Advanced Breast Cancer","Metastatic Breast Cancer","Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[180,181,182,183,184,177,185,186],"breast cancer","advanced solid tumor","advanced breast cancer","hormone receptor positive breast cancer","HER2-negative breast cancer","BGB-43395","non-small cell lung cancer",{"date":82,"type":36},{"date":189,"type":36},"2023-12-01",{"date":191,"type":21},"2028-11",{"name":138,"class":43},62,{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":212,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100370548","phase-1-a-study-of-tulmimetostat-dzr123-cpi-0209-in-patients-with-advanced-solid-tumors-and-lymphomas-100370548","NCT04104776","A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","A Phase 1\u002F2 Study of DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas","Key Inclusion Criteria:\n\nAll Patients:\n\n* Adults aged ≥18 years with life expectancy ≥12 weeks\n* ECOG performance status 0-1\n* Adequate recovery from prior therapy-related toxicities (Grade ≤1, with exceptions)\n* Adequate bone marrow, renal, and hepatic function per protocol-defined thresholds\n* Willingness to provide tumor tissue and blood samples for biomarker analyses\n* Agreement to protocol-specified contraception requirements\n* Signed informed consent prior to study procedures\n\nDisease-Specific Inclusion Criteria:\n\nPhase 1 (Dose Escalation):\n\n* Histologically or cytologically confirmed locally advanced or metastatic solid tumors or lymphoma\n* Disease refractory to standard therapy or with no available effective standard treatment\n* For prostate cancer: castrate testosterone levels maintained throughout the study\n\nPhase 2 (Disease-Specific Cohorts):\n\n* M1: ARID1A mutant urothelial carcinoma or other ARID1A mutant solid tumors (with cohort specific prior therapy and RECIST 1.1 measurable disease requirements)\n* M2: ARID1A mutant ovarian clear cell carcinoma after prior platinum-based therapy (and bevacizumab unless contraindicated)\n* M3: ARID1A mutant recurrent\u002Fmetastatic endometrial carcinoma after platinum therapy and appropriate immunotherapy\n* M4: Relapsed\u002Frefractory peripheral T cell lymphoma or diffuse large B cell lymphoma, transplant-ineligible, with measurable disease\n* M5: Relapsed\u002Frefractory pleural or peritoneal mesothelioma with documented BAP1 loss\n* M6: Metastatic castration-resistant prostate cancer (mCRPC) with documented progression after AR targeted therapy and taxane chemotherapy\n* M7: ARID1A wild type endometrial carcinoma (exploratory food-effect cohort)\n* M8: mCRPC treated with DZR123 in combination with enzalutamide, with cohort specific requirements for prior androgen receptor pathway inhibitor and chemotherapy exposure\n\nKey Exclusion Criteria:\n\nAll Patients:\n\nMedical Conditions:\n\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Active or untreated symptomatic CNS metastases (with limited exceptions)\n* Clinically significant cardiovascular disease, including uncontrolled arrhythmias or prolonged QTc\n* Active interstitial lung disease or pneumonitis\n* Uncontrolled infections or significant gastrointestinal disorders affecting absorption\n* Active HIV or hepatitis B\u002FC infection\n* Concurrent malignancy requiring active treatment (with protocol-defined exceptions)\n* Pregnancy, breastfeeding, or inability to comply with protocol requirements\n\nPrior or Concomitant Therapy:\n\n* Recent anticancer therapy within protocol-defined washout periods\n* Prior EZH2 inhibitor treatment\n* Recent radiation or liver-directed therapies outside allowed windows\n* Use of strong CYP3A4\u002F5 inhibitors or inducers\n\nAdditional Cohort-Specific Exclusions:\n\n* M6 (mCRPC): Bone-only disease, unstable bone lesions, PSA-lowering herbal products, recent prohibited prostate cancer therapies\n* M8 (Combination): PSA-only disease, prior investigational androgen receptor pathway inhibitors, significant seizure risk, extensive prior bone marrow irradiation, active inflammatory gastrointestinal disease",{"count":202,"type":21},300,[24,55],"The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.",[27,206,207,208,209,63,210,211],"Diffuse Large B Cell Lymphoma","Lymphoma, T-Cell","Mesothelioma, Malignant","Prostatic Neoplasms, Castration-Resistant","Ovarian Clear Cell Carcinoma","Metastatic Castration-resistant Prostate Cancer",[213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,63,210,230,231,232,233],"Tulmimetostat","DZR123","Lymphoma, Large B-Cell, Diffuse","Lymphoma, B-cell","Lymphoma, T-cell","Lymphoma, Non-Hodgkin","Lymphoma","Neoplasms by Site","Neoplasms by Histologic Type","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Topoisomerase Inhibitors","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents","Food effect","Adenine-thymine (AT)-rich interactive domain-containing protein 1A (ARID1A)","ARID1A wildtype (ARID1A WT) endometrial carcinoma","Metastatic castration-resistant prostate cancer (mCRPC)",{"date":82,"type":36},{"date":236,"type":36},"2019-09-18",{"date":238,"type":21},"2030-02-27",{"name":240,"class":43},"Novartis Pharmaceuticals",80,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":113},"100536106","phase-1-study-of-apr-1051-in-patients-with-advanced-solid-tumors-100536106","NCT06260514","Study of APR-1051 in Patients With Advanced Solid Tumors","A Phase 1, Open-Label, Multicenter, First-In-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APR-1051 in Patients With Advanced Solid Tumors","ACESOT-1051","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of advanced\u002Fmetastatic solid tumor\n* Measurable or evaluable disease per RECIST version 1.1 (radiographic disease progression per PCWG3 criteria for patients with mCRPC)\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 or Karnofsky Performance Status (KPS) ≥ 70%\n* Patients must have recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation\n* Adequate bone marrow and organ function\n* Women of child-bearing potential (WOCBP) or men of child-fathering potential must agree to use adequate contraception prior to study entry\n\nExclusion Criteria:\n\n* Patient has had prior systemic anti-cancer therapy (cytotoxic chemotherapy, immunotherapy, targeted therapy) within 3 weeks (6 weeks in cases of mitomycin C, nitrosourea, lomustine) or at least 5 half-lives (whichever is shorter, but no less than 2 weeks) prior to Day 1\n* Prior radiation therapy at the target lesion unless there is evidence of disease progression. If patient has had prior radiation therapy for disease progression, see Exclusion Criterion 1 for allowed interval between radiotherapy and Day 1 and recovery of AEs\n* Treatment with any investigational agent administered within 30 days or 5 half-lives, whichever is shorter, before the first dose of APR-1051\n* Major surgery within 21 days prior to Day 1\n* Concomitant treatment with other anti-cancer therapy, including chemotherapy, immunotherapy, biological therapy, radiation therapy (except palliative local radiation therapy), or other novel anti-cancer agents. Note: endocrine therapy for breast and prostate cancer is allowed along with agents to treat or prevent skeletal related events (zoledronic acid, pamidronate, denosumab)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy",{"count":251,"type":21},90,[24],"The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors.",[27],"2026-08-14",{"date":257,"type":36},"2026-08-17",{"date":259,"type":36},"2024-06-13",{"date":261,"type":21},"2028-06",{"name":263,"class":43},"Aprea Therapeutics",{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},"100610029","phase-1-an-investigational-study-of-bg-75202-alone-and-in-combination-with-other-therapeutic-agents-in-adults-with-advanced-solid-tumors-100610029","NCT07222267","An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors","A Phase 1a\u002F1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Part 1A: Participants with histologically or cytologically confirmed advanced, metastatic breast cancer and other solid tumors who have exhausted, are intolerant of all available standard of care therapies, and\u002For without available standard of care therapies.\n* Part 1B and Part 2A: Participants with advanced breast cancer with 1 to 3 prior lines of systemic therapy in the metastatic setting. Prior lines in the advanced\u002F metastatic setting may not exceed 2 lines of chemotherapy (inclusive of antibody-drug conjugate with cytotoxic payload).\n* Parts 2B and 2C: Participants with advanced breast cancer enrolled in regions where cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitors are not approved and\u002For not available as the first-line treatment and who are CDK4\u002F6 inhibitor treatment naïve and did not receive any previous systemic treatment for advanced disease.\n* Participants with breast cancer must have histologically or cytologically confirmed advanced breast cancer at the time of most recent testing, based on American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Female participants with metastatic breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior exposure to KAT6A\u002FB or KAT7 inhibitors\u002Fdegraders.\n* Patients with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n* Participants with any malignancy ≤ 3 years before screening for the study except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively which in the opinion of the investigator is unlikely to require intervention during the study.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":89,"type":21},[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75202 (KAT6A\u002FB inhibitor) alone and in combination with other therapies in participants with breast cancer and other advanced solid tumors.",[70,27],[276],"KAT6 inhibitor","2026-08-13",{"date":255,"type":36},{"date":134,"type":36},{"date":281,"type":21},"2037-01-13",{"name":138,"class":43},31,{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100564946","phase-1-safety-pharmacokinetics-and-efficacy-of-ai-081-a-bispecific-antibody-for-pd-1-and-vegf-in-advanced-solid-tumors-100564946","NCT06635785","Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors","BiPAVE-001","Inclusion Criteria:\n\n* Patient is ≥ 18 years of age on the day of signing informed consent.\n* Male or female, female patient of childbearing potential must have negative pregnancy test.\n* Patient must have a performance status of ≤ 1 on the ECOG Performance Scale.\n* Patients must have a histological or cytological diagnosis of solid tumors and have metastatic disease or locally advanced disease.\n* Measurable disease as determined by RECIST 1.1\n* Patient must have adequate organ function as indicated by the following laboratory values\n* Patient has voluntarily agreed to participate by giving written informed consent.\n* Female patients enrolled in the study, if having childbearing potential (WOCBP) and sexually active, must agree to use adequate and effective birth control starting with the first dose of study drug through 90 days after the last dose of study therapy.\n* Male patients, if sexually active, must agree to use adequate and effective methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.\n\nExclusion Criteria:\n\n* Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment. The washout period for treatment regimen containing monoclonal antibodies is 28 days. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion and therapy for non-cancer condition are allowed.\n* Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.\n* Patients who are on chronic systemic steroid therapy at doses higher than 10 mg\u002Fday prednisone or equivalent within 7 days before first treatment.\n* Patients who have brain metastases or leptomeningeal metastases.\n* Patient with a different cancer other than the one treated under this protocol, which requires systemic treatments within 24 months prior to C1D1.\n* Patient has history of grade ≥3 allergic or hypersensitivity to IV infusion medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.\n* Within past 6 months with history of significant cardiovascular acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, revascularization procedures, acute pulmonary embolism or any disorders resulted in LVEF \\\u003C 40% at the time of screening or colitis, small bowel obstruction, hepatitis or pancreatitis adrenal insufficiency, or severe immunotherapy related AE (irAE≥ grade 3).\n* Patients who have acute infections which require systemic treatments within 14 days prior to C1D1.\n* Patients who, in the opinion of the treating Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or make study participation not in the best interest of the patient, in the opinion of the treating Investigator. Investigators should discuss the case with the Sponsor and\u002For study leaders.\n* Patients with known psychiatric or substance abuse disorders may interfere with cooperation with the requirements of the trial.\n* Patients who are pregnant or breastfeeding or plan pregnancy or fathering the child during the study or within 6 months after the last dosing of study drug\n* Patients with tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels or otherwise with high risk of fatal hemorrhage\n* Uncontrolled hypertension: systolic pressure ≥ 150 millimeters of mercury (mmHg) or diastolic pressure ≥ 90 mmHg on repeated measurements that cannot be managed by standard antihypertension medications ≤ 28 days before the first dose of study drug(s).\n* Medical history of cardiovascular diseases, gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose.\n* Patients with clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage.\n* With a history of interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.",{"count":292,"type":21},387,[24,55],"BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.",[27],{"date":257,"type":36},{"date":298,"type":36},"2025-03-26",{"date":300,"type":21},"2027-12-31",{"name":302,"class":43},"OncoC4, Inc.",21,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100506498","phase-1-first-in-human-study-of-ds-3939a-in-participants-with-advanced-solid-tumors-100506498","NCT05875168","First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors","Phase 1\u002F2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n* Sign and date the main Informed Consent Form (ICF).\n* Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.\n* Has adequate organ function.\n* Measurable disease based on RECIST V1.1.\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n\nAdditional inclusion criteria for Part 1\n\n* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.\n\nAdditional inclusion criteria for Part 2\n\n* Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria\n* Is able to provide either of the following baseline tumor samples:\n\n  1. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or\n\n     * Fresh core needle biopsy sample\n     * Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual.\n  2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample.\n\nExclusion Criteria:\n\n* Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.\n* Has spinal cord compression or clinically active central nervous system metastases.\n* Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.\n* Has any history of ILD\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection.\n* Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.\n* Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n* Has an active (ie, symptomatic and\u002For on-treatment), known, or suspected autoimmune disease.\n* Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.",{"count":312,"type":21},590,[24,55],"This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.",[27,316],"Metastatic Solid Tumor",[318,319,320],"DS-3939a","Advanced\u002Fmetastatic solid tumors","Antibody drug conjugate","2026-08-11",{"date":323,"type":36},"2026-08-12",{"date":325,"type":36},"2023-08-18",{"date":327,"type":21},"2027-02-15",{"name":42,"class":43},36,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":113},"100605752","phase-1-m0324-as-monotherapy-and-in-combination-with-pembrolizumab-or-chemotherapy-in-participants-with-selected-advanced-solid-tumors-100605752","NCT07166601","M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors","An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic\u002FPharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors","TITER","Inclusion Criteria:\n\nPart 1- M0324 Monotherapy:\n\n• Participants with certain advanced\u002Fmetastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator\n\nPart 2- M0324 Combination with Pembrolizumab:\n\n• Participants with certain advanced\u002Fmetastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.\n\nPart 3- M0324 Combination with mFOLFIRINOX:\n\n* Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and\u002For adjuvant chemotherapy are not permitted\n* Other protocol defined inclusion criteria could apply\n\nExclusion Criteria:\n\n* Has a history of chronic diarrhea greater than or equal to (\\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction\n* Participant has a history of malignancy within 3 years before the date of enrollment\n* Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure \\[New York Heart Association (NYHA) \\>= II\\] or a coronary revascularization procedure within 180 days of study entry\n* Life expectancy of less than 3 months\n* Other protocol defined exclusion criteria could apply",{"count":339,"type":21},77,[24],"The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).",[27],[344,345,346,347,348,349],"Bispecific CD40 agonistic antibody","Mucin-1 (MUC-1)","pembrolizumab","mFOLFIRINOX","pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","2026-08-10",{"date":321,"type":36},{"date":353,"type":36},"2025-10-10",{"date":355,"type":21},"2029-02-23",{"name":357,"class":43},"EMD Serono Research & Development Institute, Inc.",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":370,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":44},"100565417","phase-1-anti-gd2-adc-m3554-in-advanced-solid-tumors-100565417","NCT06641908","Anti-GD2 ADC M3554 in Advanced Solid Tumors","A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced\u002Fmetastatic setting.\n* Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.\n* Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +\u002F- temozolomide, depending on the O\\^6-methylguanine-DNA methyltransferase \\[MGMT\\] status) and relapsing at least 3 months after the end of the radiotherapy treatment.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Other protocol defined inclusion criteria could apply\n\n  * Exclusion Criteria:\n* Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation\u002Fexpansion cohort) 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\u002Fhypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).\n* STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression\n* Other protocol defined exclusion criteria could apply",{"count":366,"type":21},52,[24],"The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.\n\nStudy details include:\n\nStudy Duration per participant: Approximately 4 months",[27],[371,372,373,374,375,376,377],"Glioblastoma","IDH-wildtype","Soft tissue sarcomas","GD2 prevalence","targeted therapy","TOP1 inhibitor","exatecan",{"date":323,"type":36},{"date":380,"type":36},"2024-11-08",{"date":382,"type":21},"2027-04-16",{"name":357,"class":43},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100534718","phase-1-a-study-of-mgc026-in-participants-with-advanced-solid-tumors-100534718","NCT06242470","A Study of MGC026 in Participants With Advanced Solid Tumors","A Phase 1\u002F1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\\u003C 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.",{"count":392,"type":21},250,[24],"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study.\n\nParticipants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.",[27,396,103,397,398,399,64,400,63,58,401,62,402,60,403,404,405,406,407,70,408,409],"Advanced Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Sarcoma","Castration Resistant Prostatic Cancer","Colorectal Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)",{"date":321,"type":36},{"date":412,"type":36},"2024-03-06",{"date":414,"type":21},"2028-10",{"name":416,"class":43},"MacroGenics",12,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":438},"100535398","sw-682-in-advanced-solid-tumors-100535398","NCT06251310","SW-682 in Advanced Solid Tumors","A Phase 1a\u002F1b Dose Escalation, Dose Expansion Study of SW-682 in Participants With Advanced Solid Tumors Enriched for Those With Hippo Pathway Mutations","Key Inclusion Criteria:\n\n* Histologically confirmed, metastatic, or unresectable solid cancer that has either not responded to or progressed during or after appropriate prior systemic anticancer therapy including chemotherapy, immunotherapy, radiation therapy, or appropriate targeted therapy, or for which there is no treatment available or prior SOC therapy was not tolerated and for which there is no further SOC treatment available\n* Part 1: must have one of the following:\n\n  * Mesothelioma with or without NF2 mutations\n  * Advanced solid tumors with NF2 mutations\n  * Advanced solid tumors with other Hippo pathway mutations or fusions (e.g., FAT1, LATS1\u002F2, YAP fusions; WWTR1-CAMTA1 in EHE).\n* Part 2: must have the tumor histology and oncogenic mutation or genomic aberration specific to each dose expansion cohort defined below:\n\n  * Cohort 1: Participants with mesothelioma with or without NF2 mutations\n  * Cohort 2: Participants with advanced solid tumors with NF2 mutations\n  * Cohort 3: Participants with advanced solid tumors with other Hippo pathway mutations identified during Part 1 (Phase 1a) dose escalation\n  * Cohort 4: SW-682 with appropriate combination therapy.\n* In both parts, participants should have known oncogenic mutation identified by Next Generation Sequencing or local assay\n* Must have archival tumor tissue or agree to a fresh tumor biopsy at screening\n* Measurable disease per RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤1\n* Adequate bone marrow, kidney, hepatic, and coagulation function\n\nKey Exclusion Criteria:\n\n* Evidence of symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression\n* Clinically significant cardiac disease or abnormal cardiac parameters\n* Preexistence or inheritance of a familial renal syndrome\n* Concomitant non-anti-arrhythmic medications that are known to prolong the QTc interval\n* Concomitant medicines that are known strong\u002Fmoderate inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and\u002For CYP1A2 within 14 days or 5 half-lives before the first dose of study treatment\n* Concomitant medicines that are known sensitive substrates of CYP3A4, CYP2C19, CYP2D6, CYP1A2, and\u002For CYP2B6 within 14 days or 5 half-lives before the first dose of study treatment\n* Concomitant medicines that are known sensitive substrates of PGP, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, MATE1, MATE2-K, OCT2\n* Clinically significant active infection (bacterial, fungal, or viral)",{"count":426,"type":21},186,[24],"This is a first-in-human (FIH), Phase 1a\u002F1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.",[27,208],"2026-08-07",{"date":350,"type":36},{"date":433,"type":36},"2024-07-31",{"date":435,"type":21},"2027-01-18",{"name":437,"class":43},"SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany",8,{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":446,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":448,"briefSummary":449,"conditions":450,"keywords":470,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":339},"100407463","the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":202,"type":21},[24,55],"The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[27,451,103,316,69,408,63,67,402,70,452,453,59,454,455,456,457,458,459,460,461,462,463,464,465,466,467,468,176,469],"Advanced Malignant Neoplasm","Other Cancer","Locally Advanced","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[471,472,473,474,475,476,477,478,479,480,481,482,346,483,484,485,486,487,488,489,490,491,492,493,494,495,496,497],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt",{"date":350,"type":36},{"date":500,"type":36},"2020-10-29",{"date":300,"type":21},{"name":503,"class":43},"PMV Pharmaceuticals, Inc",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":517,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":522,"leadSponsor":524,"locationsCount":525},"100645357","first-in-human-trial-of-ds1025a-in-participants-with-advanced-solid-tumors-100645357","NCT07681882","First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","A Phase 1, Multicenter, Open-label, First-in-Human Trial of DS1025a in Participants With Advanced Solid Tumors","To be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. Sign and date the main ICF, prior to the start of any trial-specific procedures.\n2. Adults ≥18 years of age at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented, advanced, metastatic, or unresectable solid tumors.\n4. Relapsed or refractory disease, following at least 1 line of therapy, not amenable to standard therapy.\n5. Is willing to provide a newly obtained tumor tissue sample at screening, if not clinically contraindicated and at an acceptable risk as determined by the Investigator. If a fresh tumor biopsy is not clinically feasible or would pose unacceptable risk, an archival tumor tissue sample (obtained within 24 months of consent) must be submitted.\n6. Has measurable disease based on local CT\u002FMRI imaging as assessment by the Investigator using RECIST v1.1; radiographic tumor assessment must be performed within 28 days prior to initiation of trial intervention.\n7. ECOG PS of 0 or 1 assessed no more than 28 days prior to initiation of trial intervention.\n8. Has adequate organ and bone marrow function as assessed by local laboratory within 14 days prior to initiation of trial intervention as defined in the protocol.\n9. A WOCBP is eligible to participate if the following conditions are met:\n\n   * Participant is not pregnant as confirmed by highly sensitive pregnancy test\n   * Participant does not plan to breastfeed during the Trial Intervention Period and for at least 8 months after last dose of trial intervention.\n   * Participant agrees to adhere to a contraceptive method that is highly effective with low user dependency only and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during the Treatment Period and for at least the time needed to eliminate the trial intervention after the last dose.\n10. A male participant capable of producing sperm is eligible to participate if he agrees to the following during the intervention period and for at least the time needed to eliminate the trial intervention:\n\n    * Avoid donating sperm.\n    * Adhere to approved contraception method as specified in the protocol.\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Prior treatment with an anti-CD25 therapy.\n2. Treatment discontinuation history due to toxicity to a DXd-ADC agent and considered not able to tolerate DS1025a based on the discussion between the investigator and the Sponsor (for participants who have DXd-ADC treatment history).\n3. Inadequate washout period before initiation of trial intervention as specified in the protocol.\n4. Has spinal cord compression or clinically active central nervous system tumors, including metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n5. Uncontrolled or significant cardiovascular disease as specified in the protocol.\n6. Any of the following within the past 6 months prior to initiation of trial intervention: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n7. Participants with any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening.\n8. Lung-specific intercurrent clinically significant illnesses as specified in the protocol.\n9. Has clinically significant pulmonary compromise or requirement for supplemental oxygen.\n10. History of other active malignancy within 3 years prior to initiation of trial intervention, with the exception of those with a negligible risk of metastasis or death (eg, 5-year OS rate \\>90%) and treated with expected curative outcome\n11. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v 6.0, Grade ≤1 or baseline.\n12. History of hypersensitivity to any excipients in DS1025a or any known contraindication to treatment with, including hypersensitivity to, the trial intervention.\n13. Has a known history of HLH.\n14. Has a known active infection, or reactivation of latent following infections as specified in the protocol among participants who received treatment such as antivirals, antifungals, or IV antibiotics within 14 days prior to first dose of trial intervention.\n15. Has active or uncontrolled HBV infection.\n16. Has active or uncontrolled HCV infection.\n17. Has active or uncontrolled HIV infection.\n18. Has an active, known, or suspected autoimmune disease.\n19. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the trial intervention.",{"count":512,"type":21},45,[24],"This clinical trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy signals of DS1025a, given as a single agent to participants with advanced, metastatic, or unresectable solid tumors.",[27,316,516],"Unresectable Solid Tumor",[27,316,516,518],"DS1025a","2026-08-06",{"date":350,"type":36},{"date":519,"type":36},{"date":523,"type":21},"2029-01-21",{"name":42,"class":43},2,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":22,"phases":535,"briefSummary":536,"conditions":537,"keywords":540,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":525},"100639442","a-first-in-human-trial-of-blu-924-sar449336-in-advanced-solid-tumors-harboring-kras-mutations-100639442","NCT07629960","A First-in-Human Trial of BLU-924 (SAR449336) in Advanced Solid Tumors Harboring KRAS Mutations","A Phase 1\u002F2, Open-Label, Dose-Escalation, Dose-Enrichment, and Dose-Expansion Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BLU-924 (SAR449336) as Monotherapy and Combination Therapy in Participants With Advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Harboring KRAS Mutations","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of metastatic Kirsten rat sarcoma viral oncogene homolog (KRAS)-mutant pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with evidence of a single KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA).\n2. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.\n4. Patients must have received all standard therapies for their cancer type in the metastatic setting, unless they are unable to receive such therapies due to clinical characteristics, comorbidities, or other medically justified reasons.\n\nExclusion Criteria:\n\n1. History of additional malignancy within the last 2 years, with some exceptions as specified in the protocol.\n2. Active brain metastases (participants with asymptomatic brain metastases may be eligible).\n3. Have received prior targeted treatment(s) against KRAS, including pan-KRAS inhibitors, multi-RAS inhibitors, mutant-selective KRAS inhibitors, and RAS or KRAS degraders.\n4. Active or uncontrolled systemic infection, such as tuberculosis, Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV).\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":534,"type":21},265,[24,55],"A first in human study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of BLU-924 \u002F SAR449336, a pan-KRAS inhibitor, in participants with advanced Pancreatic Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer harboring KRAS mutations.",[27,465,538,539],"Colorectal Neoplasms","Pancreatic Ductal Adenocarcinoma",[541,542,543,544,545,546,547,548,549,550,551,552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,458,570,571],"Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation","Metastatic Non-Small Lung Cell Cancer","Metastatic Colorectal Cancer (CRC)","Metastatic Pancreatic Ductal Adenocarcinoma","KRAS G12A","KRAS G12C","KRAS G12D","KRAS G12S","KRAS G12V","Solid Tumor, Adult","KRAS-mutant","KRAS-positive","KRAS G13D","Pan-KRAS inhibitor","KRAS inhibitor","First-in-human","Solid tumor","Advanced cancer","Adult solid tumor","Metastatic solid tumor","Colorectal cancer","Colon cancer","Rectal cancer","Metastatic colorectal cancer","Pancreatic cancer","Pancreatic ductal adenocarcinoma","PDAC","Metastatic pancreatic cancer","Lung cancer","Precision oncology","Targeted therapy",{"date":350,"type":36},{"date":574,"type":36},"2026-06-04",{"date":576,"type":21},"2031-07",{"name":578,"class":43},"Blueprint Medicines Corporation",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":22,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":417},"100577852","a-study-of-bgb-b455-in-adults-with-advanced-or-metastatic-solid-tumors-100577852","NCT06803680","A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors","A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high-grade OC (ie, ovarian cancer, fallopian tube cancer, or primary peritoneal cancer) will be enrolled in dose escalation cohorts, starting from Protocol Amendment 3.0.\n* Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.\n* Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for certain cohorts.\n* ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese \\[or other country\\] patent medicines, ≤ 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).\n* Palliative radiation treatment or other locoregional therapies ≤ 14 days before the first dose of study drug(s).\n* Live vaccine ≤ 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.\n* Any major surgical procedure ≤ 28 days before the first dose of study drug(s).\n* History of prior ≥ Grade 3 cytokine release syndrome (CRS).\n* Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":251,"type":21},[24],"The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors.\n\nThe main questions it aims to answer are:\n\n* What is the recommended dosing for BGB-B455?\n* What medical problems do participants have when taking BGB-B455?\n\nThe study has two parts:\n\n* Phase 1a: dose escalation and safety expansion\n* Phase 1b: dose expansion",[27,316],[591,592,593,594,595,596,597,598],"Claudin-6","CLDN6+","advanced or metastatic solid tumor","CD3","BsAb","bispecific antibody","CD3-BsAb","CLDN",{"date":350,"type":36},{"date":601,"type":36},"2025-03-18",{"date":603,"type":21},"2028-04-29",{"name":138,"class":43},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":610,"acronym":4,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":22,"phases":614,"briefSummary":615,"conditions":616,"keywords":617,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":628},"100562102","phase-1-study-of-bg-t187-alone-and-in-combination-with-other-therapeutic-agents-in-participants-with-advanced-solid-tumors-100562102","NCT06598800","Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid Tumors","A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-T187, an EGFR×MET Trispecific Antibody, Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.\n2. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n4. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC).\n5. ≥ 1 measurable or nonmeasurable lesion as assessed by RECIST v1.1. for Phase 1a Part A; ≥ 1 measurable lesion per RECIST v1.1. for Phase 1a Part B and Phase 1b.\n6. Adequate organ function.\n\nExclusion Criteria:\n\n1. Prior severe allergic reactions or hypersensitivity to the active ingredient and excipients of BG-T187 or other monoclonal antibodies.\n2. Spinal cord compression, active leptomeningeal disease, or uncontrolled, untreated brain metastasis.\n3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n4. History of interstitial lung disease (ILD) or noninfectious pneumonitis requiring steroids or other immune suppressive agents ≤ 2 years before the first dose of the study drug, or with current ILD\u002Fnoninfectious pneumonitis, or where suspected ILD\u002Fnoninfectious pneumonitis cannot be ruled out by imaging during screening.\n5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤14 days after intervention).\n6. Active hepatitis C.\n7. Infection (including tuberculosis infection, or other) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study drug(s).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":613,"type":21},153,[24],"This is a first-in-human (FIH), Phase 1a\u002F1b, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-T187 alone and in combination with other therapeutic agents in participants with advanced solid tumors.",[27],[618,556,619,620,621],"Advanced Solid Tumors","BG-T187","EGFR","c-MET",{"date":430,"type":36},{"date":624,"type":36},"2024-10-18",{"date":626,"type":21},"2028-09-30",{"name":138,"class":43},30,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":22,"phases":638,"briefSummary":639,"conditions":640,"keywords":642,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":656},"100559250","phase-1-a-study-of-ly4050784-in-participants-with-advanced-or-metastatic-solid-tumors-100559250","NCT06561685","A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors","An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2\u002FBRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4\u002FBRG1 Alterations","Inclusion Criteria:\n\n* Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:\n\n  * Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)\n  * Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n  * Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n  * Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.\n* Prior Systemic Therapy Criteria:\n\n  * Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.\n  * Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.\n  * Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease\n* Measurability of disease\n\n  * Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)\n  * Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nExclusion Criteria:\n\n* Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations\n* Prior exposure to SMARCA2 (BRM) inhibitor(s) and\u002For degrader(s) (prior exposure may be permitted for dose escalation)\n* Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement\n* Participants with history of increased risk of prolonged QT or significant arrythmia\n* Significant cardiovascular disease\n* Participants with active and\u002For treated for an additional primary malignancy within 2 years prior to enrolment\n* Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention\n* Participants with history of active autoimmune diseases, history of allogenic stem cell\u002Forgan transplant or compromised immune system within past 2 years (Part C only)",{"count":637,"type":21},340,[24],"The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.",[316,27,178,641],"SMARCA4-Deficient Tumor",[643,644,569,645,646,647,648,571],"SMARCA2","SMARCA4","BRM","BRG1","Adenocarcinoma","Squamous cell carcinoma",{"date":430,"type":36},{"date":651,"type":36},"2024-09-19",{"date":653,"type":21},"2027-10",{"name":655,"class":43},"Eli Lilly and Company",33,{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":663,"targetDuration":4,"studyType":22,"phases":665,"briefSummary":666,"conditions":667,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":673,"locationsCount":438},"100508504","phase-1-study-of-intratumoral-administration-of-vax014-with-expansion-in-combination-with-a-checkpoint-inhibitor-in-subjects-with-advanced-solid-tumors-100508504","NCT05901285","Phase 1 Study of Intratumoral Administration of VAX014 With Expansion in Combination With a Checkpoint Inhibitor in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age 18+\n2. Informed consent\n3. Histological or cytopathological confirmed diagnosis of a locally advanced or metastatic solid tumor\n4. Progression following at least one prior standard treatment or intolerant of standard treatments.\n5. \\[Dose Escalation\\] Availability of archival or fresh tumor tissue\n6. \\[Expansion\\] Willing to undergo biopsy of the tumor to be injected prior to the initial VAX014 injection (may provide archival tissue instead if approved by Medical Monitor)\n7. No available SOC therapy that would confer clinical benefit\n8. \\[Dose escalation\\] At least one cutaneous, subcutaneous, or nodal injectable tumor (between 1 and 10 cm in largest diameter) that can be injected by direct palpation or with the assistance of ultrasound without the need for interventional radiology\n9. \\[Expansion\\] At least one injectable tumor (\\>=0.5cm in largest diameter) that can be injected either with or without the need for interventional radiology\n10. \\[Expansion\\] Appropriate for treatment with either nivolumab or pembrolizumab\n11. \\[Expansion\\] Progression following at least one prior regimen containing PD-1 directed immune checkpoint blockade\n12. Measurable disease by RECIST v1.1\n13. ECOG Performance Status of 0, 1, or 2\n14. Resolution of any toxicity associated with prior therapy to ≤ Grade 1 (Residual toxicity of Grade 2 may be allowed following discussion with Medical Monitor)\n15. Adequate hematologic function defined as:\n\n    1. Absolute neutrophil count \\>=1,500\u002FuL\n    2. Platelet count \\>=100,000\u002FuL\n    3. \\[Expansion\\] Hemoglobin \\>=9 gm\u002FdL\n16. Adequate hepatic function defined as:\n\n    1. Total bilirubin ≤ 1.5 x ULN\n    2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN\n17. Adequate coagulation defined as:\n\n    1. International normalized ratio (INR) ≤ 1.5 x ULN or prothrombin time (PT) ≤ 1.5 x ULN\n    2. Partial thromboplastin time (PTT) or activated PTT (aPTT) ≤ 1.5 x ULN\n18. Serum creatinine ≤ 1.5 x ULN or estimated GFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (per MDRD GFR formula)\n19. Women of childbearing potential must have a negative serum pregnancy test\n20. All subjects of childbearing potential must be willing to consent to using effective contraception (as determined by the Investigator) while on treatment and for 3 months after their participation in the study ends\n\nExclusion Criteria:\n\n1. Injectable tumor not sufficiently distanced from critical structures (e.g., major airway, neurovascular structure) where post injection swelling may place the subject at unacceptable risk\n2. ≤ 21 days or ≤ five half-lives (whichever is shorter) between any prior anticancer therapy (e.g., chemotherapy, immunotherapy, intralesional therapy, irradiation) and the first injection of VAX014\n3. Known CNS metastases or leptomeningeal carcinomatosis, unless adequately treated and clinically stable off steroids for ≥ 14 days from the first injection of VAX014\n4. Severe infection requiring systemic antibiotic therapy or hospitalization for treatment of injection\n5. Need for systemic immunosuppressive therapy (≤10 mg of prednisone equivalent, or one time pulse steroids excepted)\n6. Active autoimmune disease requiring systemic immunosuppressive therapy\n7. Active lung disease or pneumonitis\n8. History of Grade 4 toxicity in response to prior PD-1 blockade\n9. Any other malignancy likely to require treatment in the next 2 years (exceptions include cancer such as basal or squamous cell skin cancers, noninvasive cancer of the cervix, and local prostate cancer)\n10. Known active infection with tuberculosis or HIV\n11. Active Hepatitis B or C\n12. \\[Females\\] pregnant or breastfeeding\n13. Clinically significant cardiovascular abnormalities including:\n\n    1. ≤ 12 months from prior MI\n    2. Unstable angina pectoris\n    3. ≤ 6 months from NYHA classification \\>=3 CHF\n14. Electrocardiogram (ECG) with QTcF \\> 450 msec (males) and QTcF \\> 470 msec (females) based on an average of triplicate ECGs (triplicate ECGs performed only if initial QTcF exceeds male\u002Ffemale limits)\n15. Medical or psychological condition that places the subject at undue risk with study participation",{"count":664,"type":21},48,[24],"The purpose of this research study is to evaluate the safety, tolerability and activity of VAX014 for intratumoral injections (VAX014) as a single agent as well as in combination with Investigator's choice of nivolumab or pembrolizumab in patients with advanced solid tumors. VAX014 is a targeted oncolytic agent designed to kill tumor cells following intratumoral injection into advanced solid tumors.",[27,668],"Advanced Solid Tumors Appropriate for Treatment With Either Nivolumab or Pembrolizumab",{"date":350,"type":36},{"date":671,"type":36},"2023-11-02",{"date":110,"type":21},{"name":674,"class":43},"Vaxiion Therapeutics",{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":4,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":682,"targetDuration":4,"studyType":22,"phases":684,"briefSummary":685,"conditions":686,"keywords":687,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":697},"100624838","phase-1-a-first-in-human-study-of-bg-c0979-in-adults-with-advanced-solid-tumors-100624838","NCT07414836","A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors","A Multicenter, Open-Label, Phase 1a\u002Fb First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Monotherapy Dose Escalation and Safety Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.\n* Phase 1b Part A (Monotherapy Dose Optimization and Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or not tolerated, or determined not appropriate based on investigator's judgment.\n* Phase 1b Part B (Combination Therapy Expansion): Participants with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors who have not received any prior systemic treatment for advanced or metastatic disease.\n* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Participants must have adequate organ function.\n\nExclusion Criteria:\n\n* Prior treatment with any ADAM9 (a disintegrin and metalloproteinase domain 9)-targeted antibody-drug conjugates (ADCs) or ADCs containing TOPO1 (DNA topoisomerase 1) inhibitor as payload.\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":683,"type":21},84,[24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 monotherapy or in combination with tislelizumab in participants with selected advanced solid tumors. The study will consist of Phase 1a (Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion).",[27],[688,689],"ADAM9 (disintegrin and metalloproteinase 9)","antibody-drug conjugate","2026-08-05",{"date":519,"type":36},{"date":693,"type":36},"2026-04-13",{"date":695,"type":21},"2029-04-30",{"name":138,"class":43},17,{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":4,"eligibilityCriteria":704,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":705,"targetDuration":4,"studyType":22,"phases":707,"briefSummary":708,"conditions":709,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":712,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":113},"100428161","safety-and-preliminary-efficacy-of-mbs81v270-in-cancer-patients-with-advanced-solid-tumours-100428161","NCT04855435","Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours","A Phase I Multicentre, Open-label, Dose Escalation Study to Determine the Safety and Preliminary Efficacy of MBS8(1V270) Administered Intravenously to Cancer Patients With Advanced Solid Tumours","Stage I Inclusion Criteria\n\n1. Male or female aged ≥18 years.\n2. Diagnosis of a histologically or cytologically confirmed solid tumour that was advanced and with progression. No standard treatment existed, or the participant refused standard treatment. Experimental immunotherapy appeared as a feasible exploratory treatment option as per Investigator's assessment.\n3. Tumour lesion(s) accessible to serial biopsies.\n4. Was willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and tumour biopsies. Mandatory Baseline and on-treatment tumour biopsies were required. However, a biopsy may have been omitted if the procedure was deemed medically unsafe or not feasible, based on the Investigator's clinical judgment and after discussion with the Medical Monitor (or Sponsor's designee).\n5. Measurable disease according to RECIST v1.1. Previously irradiated lesions were measurable if subsequent progression was documented.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.\n7. Life expectancy \\>3 months as assessed by the Investigator.\n8. Adequate bone marrow, cardiopulmonary, renal and hepatic functions:\n\n   • Haemoglobin ≥5.6 mmol\u002FL (≥90 g\u002FdL) (without transfusion or erythropoietin therapy within 4 weeks prior to therapy)\n\n   • Neutrophils ≥1.5×109\u002FL, without growth factor stimulation within 3 weeks prior to the blood test\n\n   • Platelet count ≥75×109\u002FL\n\n   • Serum creatinine ≤1.25×ULN or creatinine clearance ≥50 mL\u002Fmin (by CKD-EPI formula)\n\n   • Hepatic function: AST and ALT ≤2.5×ULN; (5×ULN in the case of liver metastases); bilirubin ≤1.5×ULN except in the case of Gilbert's syndrome and 2×ULN in the case of liver metastases.\n9. All participants of childbearing potential (defined as \\\u003C2 years after last menstruation or not surgically sterile) must have had a negative highly sensitive pregnancy test at Screening (urine\u002Fserum) and agreed to use highly effective method for contraception according to the European Union (EU) Clinical Trial Facilitation Group guidance from time of signing the informed consent form (ICF) until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must have also applied contraceptive methods and were recommended not to donate sperm.\n10. Ability to understand and sign the ICF.\n\nStage II General Inclusion Criteria The following general inclusion criteria apply to all participants unless cohort criteria specify otherwise.\n\n1. Male and female aged ≥18 years.\n2. Eastern Cooperative Oncology Group performance status 0 to 1.\n3. Life expectancy ≥3 months as assessed by the Investigator.\n4. Adequate organ function within 7 to 14 days prior to Day 1. • Absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥100×10⁹\u002FL; haemoglobin ≥9 g\u002FdL (transfusion allowed per site's policy) • Aspartate transaminase\u002FALT ≤3×ULN (≤5×ULN in case of liver metastases)\n\n   • Total bilirubin ≤1.5×ULN (≤3×ULN in case of Gilbert's syndrome)\n   * Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault or measured)\n   * International normalised ratio (INR)\u002Factivated partial thromboplastin time (APTT) within institutional limits (unless on stable anticoagulation).\n5. Prior systemic anti-cancer therapy with a washout period of ≥14 days plus resolution of drug-related AEs before C1D1. Participants should have recovered from prior therapy-related toxicities to Baseline or Grade ≤1 (except alopecia and other non-clinically significant AEs) and meet all Baseline laboratory criteria. Any deviation requires documented approval from the Sponsor\u002FMedical Monitor with justification in the source record.\n6. Major surgery ≥4 weeks, palliative radiotherapy ≥2 weeks, stereotactic body radiation therapy to lung\u002Fliver ≥3 weeks.\n7. No systemic steroids \\>10 mg\u002Fday prednisone-equivalent within 14 days before C1D1.\n\n   Note: Physiologic\u002Freplacement doses (e.g., adrenal insufficiency) up to 10 mg\u002Fday prednisone-equivalent, topical, inhaled, intra-articular, intranasal, or ophthalmic steroids are allowed.\n8. All participants of childbearing potential (defined as \\\u003C2 years after last menstruation or not surgically sterile) must have a negative highly sensitive pregnancy test at Screening (urine\u002Fserum) and agree to use highly effective method for contraception according to the EU Clinical Trial Facilitation Group guidance from the time of signing the ICF until at least 120 days after the last administration of trial drug. The partners of participants with childbearing potential must also apply contraceptive methods and are recommended not to donate sperm.\n9. Ability to provide informed consent and comply with trial procedures.\n10. Lactate dehydrogenase ≤2.0×ULN at Screening (single repeat allowed, if confounded).\n\nStage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Inclusion Criteria The following inclusion criteria apply specifically to Stage II - Cohort A. 11A. Histologically\u002Fcytologically confirmed metastatic cutaneous melanoma. 12A. Prior exposure to pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab with documented SD lasting ≥6 months, or any CR or PR followed by disease progression.\n\n13A. No untreated or unstable brain metastases. Participants with treated\u002Fstable CNS metastasis are eligible if the condition is radiographically stable for ≥4 weeks, no new\u002Fworsening neurologic symptoms, and off steroids or on stable\u002Fdeclining ≤10 mg\u002Fday prednisone-equivalent for ≥14 days.\n\n14A. Last dose of pembrolizumab, nivolumab, nivolumab + ipilimumab, or nivolumab + relatlimab was given ≤12 weeks prior to Screening, and with no other therapy started.\n\n15A. No prior Grade ≥3 irAE leading to permanent discontinuation of prior anti-PD1\u002FPD L1.\n\n16A. Willing to receive pembrolizumab per SmPC\u002Flabel-concordant schedule. Stage II - Cohort B (Uveal Melanoma; MBS8(1V270) Monotherapy) Specific Inclusion Criteria The following inclusion criteria apply specifically to Stage II - Cohort B. 11B. Histologically\u002Fcytologically confirmed metastatic uveal (ocular) melanoma. 12B. Prior tebentafusp exposure with subsequent progression.\n\n* With documented SD lasting ≥6 months, or any CR or PR\n* RECIST v1.1 progression on tebentafusp.\n* Washout ≥14 days from the last tebentafusp dose, tebentafusp-related AEs recovered to Grade ≤1\u002FBaseline.\n* No new organ crisis (e.g., hepatic failure risk, spinal cord compromise) in the prior 4 weeks.\n* No escalation of corticosteroids for tumour-related symptoms within 14 days. 13B. Prior exposure to pembrolizumab, nivolumab, or nivolumab + ipilimumab with documented SD lasting ≥6 months, or any CR or PR followed by disease progression, independent of prior tebentafusp therapy.\n\nExclusion Criteria A participant was not eligible for the trial if any of the following applied. Stage I Exclusion Criteria\n\n1. Have had biologic, hormonal, anti-neoplastic chemotherapy, or radiation therapy within 4 weeks prior to Screening (6 weeks required for nitrosourea or mitomycin) except for medications with half-lives \\\u003C5.5 days.\n2. Metastatic disease that involved major airways or blood vessels or centrally located mediastinal tumour masses of large volume with close relation to the major airways, where tumour necrosis may have caused perforation or severe bleeding episodes. Primary or metastatic intestinal disease in situ where tumour necrosis may have caused gastrointestinal perforation.\n3. Use of investigational agent in the 4 weeks or 5 half-lives prior to the first dose of MBS8(1V270), whichever was shortest.\n4. Major surgical procedure within 14 days prior to the first dose of trial treatment.\n5. Had a history of another primary malignancy, except for:\n\n   • Malignancy treated with curative intent and with no known active disease within 2 years prior to the first dose of MBS8(1V270)\n\n   • Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma\n\n   • Adequately treated uterine cervical cancer Stage 1B or less.\n6. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids \\[\\>10 mg prednisone per day or equivalent, except topical or inhaled\\] cyclophosphamide, azathioprine, methotrexate, thalidomide, anti-IL-6 receptor agents, and anti-tumour necrosis factor \\[TNF\\]α agents) within 2 weeks prior to initiation of trial treatment, or anticipation of need for systemic immunosuppressive medication during trial treatment.\n7. Treatment with androgen deprivation therapies such as luteinizing hormone-releasing hormone (LHRH) (gonadotropin-releasing hormone \\[GnRH\\]) agonists within 2 weeks prior to initiation of trial treatment.\n8. Ongoing irAEs and\u002For AEs Grade ≥2 not resolved from previous therapies except vitiligo, resolved atopy, limited psoriasis, stable neuropathy Grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy.\n9. Had uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, human immunodeficiency virus (HIV), immune dysfunction such as autoimmune disease, psychiatric illness such as depression or suicidal tendency or social situations that would have limited compliance with trial requirements.\n10. Had active or history of immunologic-mediated disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, or Guillain-Barré syndrome.\n11. Had clinically significant cardiac disease, including:\n\n    • Known congestive heart failure Grade III or IV by the New York Heart Failure Association (see Appendix A)\n    * Myocardial infarction within 6 months prior to signing the ICF\n    * Onset of unstable angina within 6 months prior to signing the ICF.\n12. History of severe allergic episodes.\n13. Known hypersensitivity to any component of MBS8(1V270).\n14. Had a history of seizure disorders uncontrolled on medication.\n15. Had a history of clinically significant coagulation or bleeding disorders or abnormalities.\n16. Abnormal or clinically significant coagulation parameters (i.e., INR and APTT) at the discretion of the Investigator.\n\n    Participants treated with anticoagulants were excluded if the coagulation parameters were outside the therapeutic intervals as described in the SmPC for the administered treatment.\n17. Women of childbearing potential who denied remaining abstinent (refrain from heterosexual intercourse) or did not use a highly effective form of contraception that resulted in a failure rate of \\\u003C1% per year during the Treatment period and up to 120 days after the last trial drug administration.\n18. Men of reproductive potential who denied following accepted contraception methods during the Treatment and up to 120 days after the last trial drug administration.\n19. Pregnant or lactating women.\n20. Had a history or current evidence of any condition, therapy, or laboratory abnormality that might have confounded the results of the trial, interfered with the participant's participation for the full duration of the trial, made administration of the trial drugs hazardous, or made it difficult to monitor adverse effects such that it was not in the best interest of the participant to participate, and in the opinion of the treating Investigator.\n21. Had an autoimmune disorder requiring immune-modulating treatment (\\>10 mg prednisone per day or equivalent, except topical or inhaled) during the last 2 years prior to the first dose of MBS8(1V270).\n\nStage II General Exclusion Criteria The following general exclusion criteria apply to all participants unless cohort criteria specify otherwise.\n\n1. Uncontrolled intercurrent illness: active infection requiring IV therapy, uncontrolled congestive heart failure, unstable angina, significant arrhythmia, recent myocardial infarction (≤6 months), or uncontrolled hypertension.\n2. Known active HIV with uncontrolled viraemia, active hepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) with high viral load (HBV \\>20,000 IU\u002FmL and HCV \\>800,000 IU\u002FmL) despite therapy (enrol per local guidelines, if controlled).\n3. Pregnant or breastfeeding.\n4. Second malignancy requiring active therapy (except adequately treated non-melanoma skin cancers, in situ cancers, or malignancies in remission ≥2 years)\n5. Allergy\u002Fhypersensitivity to trial drug components.\n6. Live vaccines within 28 days prior to C1D1.\n7. QTcF \\>500 ms.\n8. Any condition that, in the Investigator's judgement, compromises safety or compliance.\n9. Active autoimmune disease requiring systemic treatment in the past 2 years (topicals\u002Finhaled\u002Fphysiologic replacement allowed).\n10. Any prior exposure to systemic or IT immunotherapy (except tebentafusp, pembrolizumab, nivolumab, ipilimumab, and relatlimab), but including Montanide, TLR7, TLR8, and TLR9 agonists, polyinosinic:polycytidylic acid, cationic adjuvant formulation, messenger ribonucleic acid -based vaccines, T cell therapy, and oncolytic viruses.\n11. Participants who have been previously treated with experimental anti-cancer vaccines.\n\nStage II - Cohort A (Cutaneous Melanoma; Pembrolizumab in Combination with MBS8(1V270)) Specific Exclusion Criteria The following exclusion criteria apply specifically to Stage II - Cohort A. 12A. Prior life-threatening or Grade ≥3 immune-related toxicity to immune checkpoint inhibitors requiring permanent discontinuation of these therapies (exception: controlled endocrinopathies on replacement).\n\n13A. Interstitial lung disease\u002Fpneumonitis (current or history requiring steroids).\n\n14A. Concurrent anti-cancer therapy other than trial-allowed supportive care. 15A. Histologically\u002Fcytologically confirmed cutaneous acral melanoma and mucosal melanoma.\n\nStage II - Cohort B (Uveal Melanoma, MBS8(1V270) Monotherapy) Specific Exclusion Criteria The following exclusion criteria apply specifically to Stage II - Cohort B. 12B. Active, uncontrolled hepatic dysfunction not attributable to tumour (e.g., acute hepatitis).\n\n13B. Any contraindication specific to MBS8(1V270) per IB (e.g., known hypersensitivity to excipients, cohort-specific risk factors).\n\n14B. Brain metastases.",{"count":706,"type":21},106,[24],"The Phase I trial is evaluating safety, tolerability, pharmacokinetics and preliminary efficacy of MBS8(1V270) in subjects with advanced solid tumours. The trial is designed to provide data for further clinical development of MBS8(1V270)",[27,710,711],"Uveal Melanoma, Metastatic","Cutaneous Melanoma",{"date":350,"type":36},{"date":714,"type":36},"2021-04-12",{"date":716,"type":21},"2027-06",{"name":718,"class":43},"MonTa Biosciences ApS",{"id":720,"slug":721,"hasResults":12,"nctId":722,"briefTitle":723,"officialTitle":724,"acronym":4,"eligibilityCriteria":725,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":726,"targetDuration":4,"studyType":22,"phases":728,"briefSummary":729,"conditions":730,"keywords":731,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":752,"lastUpdatePostDateStruct":753,"startDateStruct":754,"completionDateStruct":756,"leadSponsor":758,"locationsCount":760},"100650606","phase-1-a-study-to-evaluate-arv-6723-alone-and-with-pembrolizumab-in-participants-with-advanced-solid-tumors-100650606","NCT07749586","A Study to Evaluate ARV-6723 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors","A Phase 1\u002F2 Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ARV-6723 Administered as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\nPart A1 dose escalation and A2 dose optimization: Participants must meet all of the following criteria:\n\n* Have a histologic or cytologic diagnosis of unresectable or metastatic solid tumor malignancy.\n* Have previously received at least one prior therapy targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), cytotoxic T-lymphocyte antigen 4 (CTLA-4), lymphocyte-activation gene 3 (LAG-3), and\u002For another T-cell co-stimulatory or immune checkpoint pathway, in any treatment setting (including neoadjuvant or adjuvant).\n* Have received prior SOC therapy appropriate for their disease type and stage and have no remaining available treatment options with established clinical benefit; or, in the opinion of the investigator, are unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy; or have declined SOC therapy.\n* Participants must have demonstrated radiographic progression and have at least 1 measurable lesion per RECIST v1.1 that has not been previously irradiated or has demonstrated progression of disease since radiation therapy.\n* ECOG PS 0 or 1 or equivalent. Participants with ECOG PS 2 may be considered upon discussion with the Sponsor Medical Monitor.\n* Participants with adequate organ function.\n\nExclusion Criteria:\n\nExclusion Criteria (Part A)\n\n* Active brain metastases (new lesions identified on imaging, existing lesions showing progression per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)\u002Fimaging characteristics or by clinical criteria, lesions requiring active interventions for symptom control).\n* Carcinomatous meningitis.\n* Known or suspected hypersensitivity to ARV-6723 or pembrolizumab or any of its excipients.\n* Active autoimmune disease or history of autoimmune diseases that may relapse.\n* History of severe immune-related adverse events (irAE) attributed to prior anti-PD-1\u002Fanti-CTLA-4\u002Fanti-LAG-3 therapy.\n* Prior treatment with any HPK1-targeting agent\n* Systemic anti-cancer therapy or radiation therapy within 14 days prior to study treatment start.\n* Current use of any prohibited concomitant medication(s) or herbal supplements which cannot be discontinued, prior to start of study intervention and for the duration of the study.\n* Baseline (screening) standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.",{"count":727,"type":21},499,[24,55],"This is a study to evaluate the safety and potential anti-tumor activity of an investigational drug called ARV-6723, in participants with advanced solid tumors.\n\nThis is an open-label study which means that participants and study staff will know that all participants will receive ARV-6723. The investigational drug ARV-6723 will be given as an oral tablet on its own and also in combination with other drugs.\n\nResearchers think that ARV-6723 can help the body's immune system to better recognize, attack, and destroy cancer cells in adults with advanced solid tumors. ARV-6723 is an investigational drug, and this is the first time ARV-6723 will be used in humans.\n\nDepending on the treatment assignment, the investigational drug, ARV-6723, will be given as an oral tablet either on its own (monotherapy) or in combination with pembrolizumab, either through a vein (intravenously or IV) or through an injection beneath the skin (subcutaneously or SQ).\n\nThis study will include multiple parts:\n\nIn Part A1 (Phase 1a), different small groups of participants will receive lower to higher doses of ARV-6723 as monotherapy or in combination with standard-dose of pembrolizumab.\n\nIn Part A2 (Phase 1b), two groups of participants with specific tumor indication(s) (TBD) will receive one of two doses selected based on information from Part A1.\n\nDetails of Part B will be determined based on information generated from Part A.",[27],[732,733,734,735,736,737,738,58,739,740,741,742,743,744,745,746,73,747,748,749,750,751],"Advanced solid tumors","PROTAC","HPK1","MAP4K1","Immune checkpoint inhibitor","Non-small cell lung cancer (NSCLC)","Renal cell carcinoma (RCC)","Gastric cancer","Gastroesophageal cancer","Esophageal cancer","Head and Neck Squamous cell carcinoma (HSNCC)","Urothelial carcinoma (UC)","Colorectal Cancer (CRC)","Triple-negative breast cancer (TNBC)","Ovarian cancer","Merkel cell carcinoma","Skin squamous cell carcinoma (SCC)","Nasopharyngeal carcinoma","Small cell lung cancer (SCLC)","Hepatocellular carcinoma (HCC)","2026-08-04",{"date":519,"type":36},{"date":755,"type":36},"2026-07-29",{"date":757,"type":21},"2032-03-31",{"name":759,"class":43},"Arvinas Inc.",3]