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COMPANY

OncoC4

HQ: Rockville, MD source · oncoc4.com ↗

Clinical Phase 3

Keywords: oncology neurology cancer Non Small Cell Lung Cancer Ovarian Cancer High Grade Serous Adenocarcinoma of Ovary Primary Peritoneal Carcinoma Fallopian Tube Cancer Gastric Cancer Esophageal Cancer Cervical Cancer Metastatic Melanoma Metastatic Head and Neck Carcinoma Metastatic Renal Cell Carcinoma Metastatic Colorectal Cancer Sarcomas Metastatic Prostate Cancer Small Cell Lung Cancer Metastatic Breast Cancer Pancreas Cancer Gastroesophageal Junction Adenocarcinoma Adenoid Cystic Carcinoma Salivary Gland Cancer Urothelial Carcinoma Melanoma Head and Neck Squamous Cell Carcinoma Endometrial Cancer Renal Cell Carcinoma Bladder Cancer Gastroesophageal-junction Cancer Colorectal Cancer Anal Cancer Hepatocellular Carcinoma Bile Duct Cancer Metastatic Castration-resistant Prostate Cancer ONC-392 ONC-841 AI-061 ONC-783 Gotistobart AI-081

Location: Rockville, MD · source · Oct 15, 2026

Profile checked Oct 10, 2026

10Trials (company is sponsor)2NIH grants

Raises and deals from press releases

From the company’s own releases; this list is partial. All raises and deals

Timeline

  1. Trial start Phase 1: Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid Tumors source ↗
  2. Trial start Phase 3: Gotistobart Long Term Extension (LTE) Study source ↗
  3. Raise Series B · about $50M source ↗
  4. Trial start Phase 1/Phase 2: Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid Tumors source ↗
  5. Trial start Phase 1: Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors source ↗
  6. Trial start Phase 1/Phase 2: ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC source ↗
  7. Trial start Phase 1: Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors source ↗
  8. Trial start Phase 3: ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors source ↗
  9. Trial start Phase 2: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer source ↗
  10. Trial start Phase 1/Phase 2: Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC source ↗
  11. Trial start Phase 1: Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841 source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 10

RecordTitlePhaseStatusStartPrimary completion
NCT05446298ONC-392 and Pembrolizumab in Platinum Resistant Ovarian CancerPhase 2Active, not recruitingDec 22, 2022Aug 30, 2026 (actual)
NCT04140526Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLCPhase 1/Phase 2Active, not recruitingSep 16, 2020Dec 31, 2026 (estimated)
NCT05858736Safety, PK and Efficacy of AI-061 in Advanced Solid TumorsPhase 1CompletedJul 11, 2023Jul 31, 2026 (actual)
NCT07408258Safety, Pharmacokinetics (PK), and Efficacy of ONC-783 in Advanced Solid TumorsPhase 1RecruitingAug 10, 2026Aug 1, 2027 (estimated)
NCT07659379Gotistobart Long Term Extension (LTE) StudyPhase 3Enrolling by invitationJul 28, 2026Jul 1, 2036 (estimated)
NCT06635785Safety, Pharmacokinetics, and Efficacy of AI-081, a Bispecific Antibody for PD-1 And VEGF in Advanced Solid TumorsPhase 1/Phase 2RecruitingMar 26, 2025Jun 30, 2027 (estimated)
NCT05671510ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 InhibitorsPhase 3Active, not recruitingJun 28, 2023Aug 31, 2027 (estimated)
NCT06352359Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid TumorsPhase 1RecruitingAug 23, 2024Sep 30, 2027 (estimated)
NCT05682443ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPCPhase 1/Phase 2Active, not recruitingDec 11, 2023Nov 30, 2026 (estimated)
NCT06219499Safety, Tolerability, Immunogenicity and Pharmacokinetics of ONC-841Phase 1Withdrawn2024-062025-06 (estimated)

NIH awards 2

Annual award amounts. Total $2.0M.

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