Drugs / ONC-392
Trials 6 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05142189 | Jun 2022 → Feb 2030 expected | non-small cell lung carcinoma | BioNTech SE | Recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05682443 | Dec 2023 → Nov 2026 expected | prostate carcinoma | OncoC4, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04140526 | Sep 2020 → Jun 2026 overdue | adenoid cystic carcinoma, breast cancer, cervical cancer, colorectal cancer +14 | OncoC4, Inc. | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05446298 | Dec 2022 → Aug 2026 overdue | fallopian tube cancer, ovarian serous adenocarcinoma, primary peritoneal carcinoma | OncoC4, Inc. | Active not recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07659379 | Jul 2026 → Jul 2036 expected | neoplasm | OncoC4, Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05671510 | Jun 2023 → Aug 2027 expected | non-small cell lung carcinoma | OncoC4, Inc. | Recruiting | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-01-12 | BioNTech SE | BioNTech and OncoC4 Receive FDA Orphan Drug Designation for Gotistobart in Squamous Non-Small Cell Lung Cancer biontech.com ↗ |
| 2025-12-06 | BioNTech SE | BioNTech and OncoC4 Announce Clinically Meaningful Overall Survival Benefit for Selective Treg Modulator Gotistobart in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer biontech.com ↗ |
| 2023-06-29 | BioNTech SE | BioNTech and OncoC4 Initiate Pivotal Phase 3 Trial of BNT316/ONC-392 Program in Metastatic NSCLC biontech.com ↗ |
| 2023-06-02 | BioNTech SE | BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO biontech.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ONC-392 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05682443 ↗ |
| Known as | BNT316 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05142189 ↗ |
| Known as | Gotistobart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05671510 ↗ |
| Action | Inhibit | “next generation anti-CTLA-4 antibody” NCT05446298 ↗ |
| Modality | Monoclonal antibody | “ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody” NCT04140526 ↗ |
| Route | Intravenous | “ONC-392 will be given by intravenous infusion” NCT04140526 ↗ |
| Target | CTLA4 | “ONC-392 is a highly selective, humanized monoclonal IgG1-kappa isotype antibody against CTLA-4.” NCT04140526 ↗ |