[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"OncoC4, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":125},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,61,80,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100543168","phase-1-safety-pharmacokinetics-pk-and-efficacy-of-onc-841-in-advanced-solid-tumors-100543168",false,"NCT06352359","Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors","Inclusion Criteria:\n\n* Must have ECOG score ≤ 1. The body weight should be ≥40 kg.\n* A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease.\n* Must have measurable target lesion according to RECIST V1.1.\n* Adequate organ function as determined by laboratory tests.\n* Voluntary agreement to participate as evidenced by written informed consent.\n* Female patient: negative pregnancy test and agreement on contraceptive methods.\n* Male patient: agreement on contraceptive methods.\n* Agree to give archival or other diagnostic tissue recut slides or an optional new tumor biopsy.\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.\n* The washout period for cancer therapeutic drugs should be 5 half-life or 21 days for chemotherapy, whichever is shorter; or 28 days for monoclonal antibody therapy. 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 conditions 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 active brain metastases or leptomeningeal metastases. Patients who have active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated, and patients are asymptomatic or neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment). Note: Patients with previously treated brain metastases may participate provided they are radiologically stable (i.e. no evidence of progression for ≥4 weeks by repeat imaging performed during study screening), clinically stable, and not requiring steroid treatment within 14 days before the first dose of study treatment.\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","ALL","18 Years",{"count":18,"type":19},72,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","This is a Phase I\u002FII open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced\u002Fmetastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.",[25],"Advanced Solid Tumor","RECRUITING","2026-06-22",{"date":29,"type":30},"2026-06-25","ACTUAL",{"date":32,"type":30},"2024-08-23",{"date":34,"type":19},"2027-09-30",{"name":36,"class":37},"OncoC4, Inc.","INDUSTRY",8,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100641642","phase-3-gotistobart-long-term-extension-lte-study-100641642","NCT07659379","Gotistobart Long Term Extension (LTE) Study","Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in Gotistobart Trials","Inclusion Criteria:\n\n1. Age ≥ 18 yrs old patients who provide written informed consent for the study.\n2. Patients must have a confirmed diagnosis of advanced unresectable or metastatic solid tumors treated on the parent gotistobart trials that Sponsor designated as PRESERVE-100 transition-ready.\n3. Patients are currently enrolled\u002Frandomized and received gotistobart or gotistobart based combination therapy. Patients could be in active treatment or in survival follow up in parent trials.\n\nExclusion Criteria:\n\n1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of roll-over in this extension study.\n2. Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient.\n3. Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study.\n4. Permanent discontinuation of gotistobart or combination therapy for any reason during the parent study, or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable). Exception: Participants who permanently discontinued gotistobart from parent studies remain eligible for enrollment in this study if the parent study permitted continued treatment with the combination agent(s) following discontinuation of gotistobart.\n5. Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study.\n6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications.\n7. Concurrent participation in any therapeutic clinical trial (other than the parent study).\n8. Pregnant, lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment in the parent trial.",{"count":47,"type":19},20,[49],"PHASE3","This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.",[25],"NOT_YET_RECRUITING","2026-06-18",{"date":55,"type":30},"2026-06-23",{"date":57,"type":19},"2026-07-01",{"date":59,"type":19},"2037-01-01",{"name":36,"class":37},{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":20,"phases":69,"briefSummary":70,"conditions":71,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100624332","phase-1-safety-pharmacokinetics-pk-and-efficacy-of-onc-783-in-advanced-solid-tumors-100624332","NCT07408258","Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors","A Multicenter, Open-label Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 yrs old.\n* Male or Female\n* Must have ECOG score ≤ 1. The body weight should be ≥40 kg. The life expectance should be estimated ≥ 12 weeks.\n* A histological or cytological diagnosis of metastatic or locally advanced pancreatic cancer, ovarian cancer, colorectal cancer, or breast cancer.\n* Must have measurable target lesion according to RECIST V1.1.\n* Adequate organ function as determined by laboratory tests.\n* Voluntary agreement to participate as evidenced by written informed consent.\n* Female patient of childbearing potential: negative pregnancy test and agreement on highly effective contraceptive methods.\n* Male patient: agreement on contraceptive methods.\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 Grade ≤ 2 chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled Grade ≤ 2 endocrine immune-related AEs are considered stable and eligible for enrollment.\n* The washout period for cancer therapeutic drugs (such as chemotherapy, radiation or targeted therapy) is 21 days or 28 days for monoclonal antibody therapy. 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 is allowed. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, growth factors and therapy for non-cancer conditions 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 active brain metastases or leptomeningeal metastases. Patients are eligible if brain metastases are adequately treated or not felt to require local treatment (i.e. \\\u003C 10 mm asymptomatic) and patients are asymptomatic or neurologically stable (except for residual signs or symptoms related to the central nervous system (CNS) treatment). Note: Patients with previously treated brain metastases may participate provided that they are radiologically stable, clinically stable, and not requiring steroid treatment within 14 days before the first dose of study treatment.\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 SC injected medications, or severe allergic reactions to food, pollen, oral medications, or atopic dermatitis or asthmatic episodes that required hospitalization.\n* QTcF (QT interval corrected for heart rate using Fridericia formula) \\>480 msec on screening ECG\n* Within past 6 months with history of significant cardiovascular events including acute myocardial infarction, acute coronary syndrome, ischemic or hemorrhagic stroke, heart failure NYHA class III or IV, or revascularization procedures.\n* Patients who have acute infections which require systemic IV drug treatments within 7 days prior to C1D1. Oral drug or prophylaxis treatment is allowed.\n* Patients who, in the opinion of the treating Investigator, have a history or current evidence of any medical or psychiatric conditions that would limit their ability to comply with all aspects of the trial or on a therapy, or with a significant 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. Investigators should discuss the case with the Sponsor.\n* Patients who are pregnant or breastfeeding, or who intend to become pregnant or father a child during the study or within 6 months after the last dosing of study drug.",{"count":47,"type":19},[22],"ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced\u002Fmetastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer.",[25],"2026-06-01",{"date":74,"type":30},"2026-06-04",{"date":72,"type":19},{"date":77,"type":19},"2028-06-01",{"name":36,"class":37},2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":20,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100490852","phase-3-onc-392-versus-docetaxel-in-metastatic-nsclc-that-progressed-on-pd-1pd-l1-inhibitors-100490852","NCT05671510","ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1\u002FPD-L1 Inhibitors","Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers That Progressed on PD-1\u002FPD-L1 Inhibitors","PRESERVE-003","Inclusion Criteria (Major criteria):\n\n1. Adult (≥ 18 years), all genders, capable of signing informed consent.\n2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs.\n3. Radiographic progression after treatment with the most recent line of treatment being either 3a or 3b:\n\n   1. At least 12 weeks of PD-1\u002FPD-L1 inhibitor in combination with platinum-based chemotherapy;\n   2. Prior treatment with at least 2 cycles of a platinum-based chemotherapy, followed by at least 12 weeks of standard doses of PD-1 or PD-L1 inhibitor-based immunotherapy.\n\n   Antibodies against CTLA-4, LAG-3, TIGIT, VEGF or VEGFR in combination with PD-1\u002FPD-L1 inhibitor are allowed.\n4. At least one measurable tumor lesion according to RECIST 1.1.\n5. ECOG score of 0 or 1.\n6. Adequate organ functions. Serum LDH level ≤ 2xULN.\n7. Life expectancy ≥ 3 months.\n\nExclusion Criteria (Major criteria):\n\n1. Cancer treatment related AEs have not recovered to NCI CTCAE grade≤ 1 except endocrinopathy.\n2. Last anti-PD-1\u002FPD-L1 dosing within 28 days prior to first dose of study treatment.\n3. Receiving systemic steroid therapy with \\>10 mg\u002Fday prednisone or equivalent within 7 days prior to the first dose of study treatment.\n4. Having documented actionable mutations or genomic alterations in any of the following genes: EGFR, ALK, ROS1, HER2, MET, BRAF, RET or NTRK;. Exception: KRAS mutations are not excluded.\n5. Patients who have symptomatic brain metastasis. Palliative radiotherapy or radiosurgery to brain metastasis within 14 days of the first dose of study drug.\n6. Active GI disease, including peptic ulcer disease, pancreatitis, diverticulitis, or inflammatory bowel disease.\n7. Active interstitial lung disease (ILD) or non-infectious pneumonitis.\n8. Active infections with IV antibiotics within 14 days prior to first dose of study treatment.\n9. Impaired heart function.",{"count":89,"type":19},630,[49],"The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392\u002FBNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1\u002FPD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.",[93],"Non Small Cell Lung Cancer","2026-04-23",{"date":96,"type":30},"2026-04-29",{"date":98,"type":30},"2023-06-28",{"date":100,"type":19},"2028-08-31",{"name":36,"class":37},152,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":20,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"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":111,"type":19},387,[22,113],"PHASE2","BIPAVE-001 is a Phase 1-2 study for evaluating the safety, pharmacokinetics (PK), and efficacy of AI-081 in solid tumors.",[25],"2026-04-08",{"date":118,"type":30},"2026-04-09",{"date":120,"type":30},"2025-03-26",{"date":122,"type":19},"2027-12-31",{"name":36,"class":37},19,""]