Drugs / ONC-392
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 → Dec 2026 expected | 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 · 1 met primary | ||||||
| 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 | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | BioNTech SE | Results BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients biontech.com ↗
The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with standard-of-care chemotherapy in this patient population. |
| 2026-09-14 | OncoC4, Inc. | Results BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients oncoc4.com ↗
The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with standard-of-care chemotherapy in this patient population. |
| 2026-05-22 | BioNTech SE | Results BioNTech to Showcase Progress Across Late-Stage Oncology Pipeline at the 2026 ASCO Annual Meeting biontech.com ↗
Data from the Phase 2 PRESERVE-004 clinical trial ( NCT05446298 ) evaluating gotistobart plus pembrolizumab in heavily pre-treated patients with platinum-resistant ovarian cancer (“PROC”) showed durable anti-tumor activity and clinically meaningful overall survival outcomes. |
| 2026-03-24 | BioNTech SE | Results BioNTech Clinical Data at ELCC 2026 Highlight Potential of Differentiated Late-Stage Portfolio in Lung Cancer biontech.com ↗
showed clinically meaningful antitumor activity, an overall survival benefit with a 54% reduction in the risk of death compared with standard of care chemotherapy |
| 2026-01-12 | BioNTech SE | Regulatory BioNTech and OncoC4 Receive FDA Orphan Drug Designation for Gotistobart in Squamous Non-Small Cell Lung Cancer biontech.com ↗
BioNTech SE (Nasdaq: BNTX, “BioNTech”) and OncoC4, Inc. (“OncoC4”) today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous NSCLC, an aggressive subtype of lung cancer with limited therapeutic options in the advanced stage. |
| 2026-01-12 | OncoC4, Inc. | Regulatory BioNTech and OncoC4 Receive FDA Orphan Drug Designation for Gotistobart in Squamous Non-Small Cell Lung Cancer oncoc4.com ↗ |
| 2025-12-06 | BioNTech SE | Results 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 ↗
Gotistobart demonstrated a clinically meaningful overall survival (“OS”) benefit compared to standard-of-care chemotherapy and a manageable safety profile in sqNSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. |
| 2025-12-06 | OncoC4, Inc. | Results 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 oncoc4.com ↗
Gotistobart demonstrated a clinically meaningful overall survival (“OS”) benefit compared to standard-of-care chemotherapy and a manageable safety profile in sqNSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. |
| 2025-10-27 | OncoC4, Inc. | Regulatory China’s NMPA Grants Breakthrough Therapy Designation for Anti-CTLA-4 Antibody Candidate Gotistobart (BNT316/ONC-392) oncoc4.com ↗
OncoC4 announced today that China’s National Medical Product Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for gotistobart (BNT316/ONC392) for the treatment of patients with squamous non-small cell lung cancer (sqNSCLC) who have progressed on prior standard immuno-oncology therapies (IO). |
| 2025-05-27 | BioNTech SE | Results BioNTech to Present Progress Across Diversified Oncology Pipeline at the 2025 ASCO Annual Meeting biontech.com ↗
Data from the PRESERVE-001 clinical trial ( NCT04140526 ) in patients with advanced melanoma indicated a manageable safety profile and early signs of anti-tumor activity. |
| 2023-10-31 | BioNTech SE | Results BioNTech to Present Clinical and Preclinical Data Updates Across Multiple Immuno-Oncology Programs at 2023 SITC Annual Meeting biontech.com ↗
The results show encouraging anti-tumor activity for BNT316/ONC-392 as monotherapy in patients with immuno-oncologic (IO)-resistant NSCLC, as well as a manageable safety profile. |
| 2023-06-02 | BioNTech SE | Results BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO biontech.com ↗
The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile. |
| 2023-06-02 | OncoC4, Inc. | Results BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO oncoc4.com ↗
The preliminary results show encouraging clinical anti-tumor activity for BNT316/ONC-392 as a monotherapy in a hard-to-treat patient population, as well as a manageable safety profile. |
| 2022-11-07 | OncoC4, Inc. | Results OncoC4 to Present Positive Data from Ongoing Phase 1/2 PRESERVE-001 Trial of ONC-392 in Combination with pembrolizumab at SITC 2022 oncoc4.com ↗
30% ORR and 90% DCR in evaluable patients were achieved in the dose escalation portion of the study in metastatic cancer patients |
| 2022-04-26 | OncoC4, Inc. | Regulatory Oncoc4 Announces Fast Track Designation Granted By The U.S. FDA For ONC-392 Monotherapy In PD(L)1-Resistant NSCLC oncoc4.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ONC-392 |
| 2021-11-09 | OncoC4, Inc. | Results OncoC4, Inc. Reports Phase Ia Data on Safety and Clinical Activities of ONC-392 (Nextgen Anti-CTLA-4) Monotherapy for Stage IV Solid Tumors oncoc4.com ↗
Most notably, in the 10 mg/kg dose cohort of six total patients, one patient with non-small cell lung cancer (NSCLC) and one patient with ovarian cancer had complete responses (CR). |
| 2019-12-30 | OncoC4, Inc. | Regulatory OncoImmune Announces Approval of IND Application for ONC-392 – The anti-CTLA-4 Antibody that Preserves CTLA-4 Recycling for Better Safety and Efficacy oncoc4.com ↗
OncoImmune, Inc. announced today that its Investigational New Drug (“IND”) application for ONC-392, its novel, next generation anti-CTLA-4 antibody, has been approved by the U.S. Food and Drug Administration (“FDA”). |
All press releases naming this drug 24 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 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 | 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 ↗ |