Gotistobart
Gotistobart is an experimental monoclonal antibody from OncoC4 in phase 3 trials for non-small-cell lung cancer, melanoma and head and neck squamous cell carcinoma, aimed at CTLA-4.
Overview
Gotistobart (ONC-392, BNT316) is a monoclonal antibody developed by OncoC4. Its target is CTLA-4 (the sponsor names CTLA-4). The sponsor states: CTLA-4 checkpoint inhibition, in some regimens combined with pembrolizumab or Pluvicto. ClinicalTrials.gov describes the intervention as: Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose. It is the investigational product in 3 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT05671510 (ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors), in non-small-cell lung cancer, melanoma, head and neck squamous cell carcinoma, renal cell carcinoma and colorectal cancer. The largest, NCT04140526, plans to enrol 733 participants with primary completion expected 2026-06-30. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas · Lines of therapy.
Trials
topTrials recruiting now
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials
Latest papers
topQuery for this drug: (TITLE:"Gotistobart" OR ABSTRACT:"Gotistobart" OR TITLE:"ONC-392" OR ABSTRACT:"ONC-392" OR TITLE:"BNT316" OR ABSTRACT:"BNT316" OR TITLE:"A humanized anti-CTLA4 IgG1 monoclonal antibody" OR ABSTRACT:"A humanized anti-CTLA4 IgG1 monoclonal antibody") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gotistobart, not a curated reading list.
Similar pages
not linked directly; found by shared links- TreatmentJK08
Shares CTLA-4, Renal cell carcinoma, Bladder & urothelial cancer, Ovarian cancer and the tags pipeline, ctgov-ingest.
- TreatmentT3011
Shares Sarcomas (soft tissue, bone, GIST), Bladder & urothelial cancer, Head and neck squamous cell carcinoma, Melanoma and the tags pipeline, ctgov-ingest.
- TreatmentXNW27011
Shares Ovarian cancer, Gastric & gastro-oesophageal junction cancer, Pancreatic ductal adenocarcinoma, Colorectal cancer and the tags pipeline, ctgov-ingest.
- TreatmentSHR-8068
Shares Bladder & urothelial cancer, Cervical cancer, Gastric & gastro-oesophageal junction cancer, Colorectal cancer and the tags pipeline, ctgov-ingest.
- TreatmentMCLA-129
Shares Oesophageal cancer, Gastric & gastro-oesophageal junction cancer, Head and neck squamous cell carcinoma, Colorectal cancer and the tags pipeline, ctgov-ingest.
- TreatmentPF-08634404
Shares Renal cell carcinoma, Oesophageal cancer, Bladder & urothelial cancer, Ovarian cancer and the tags pipeline, ctgov-ingest.
- TreatmentIBI363
Shares Renal cell carcinoma, Melanoma, Colorectal cancer, Non-small-cell lung cancer and the tags pipeline, ctgov-ingest.
- TreatmentSHR-A2102
Shares Bladder & urothelial cancer, Cervical cancer, Head and neck squamous cell carcinoma, Non-small-cell lung cancer and the tags pipeline, ctgov-ingest.