{"entity":{"id":"gotistobart","kind":"drug","name":"Gotistobart","aka":["A humanized anti-CTLA4 IgG1 monoclonal antibody"],"tldr":"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.","summary":"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 was scheduled for 2026-06-30 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Gotistobart","url":"https://clinicaltrials.gov/search?intr=ONC-392"},{"label":"Sponsor page","url":"https://www.oncoc4.com/en/pipeline/pipeline/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","melanoma","head-and-neck","rcc","colorectal","sarcoma","prostate","ovarian","breast-hr-positive","pancreatic","gastric","esophageal","cervical","salivary-gland","mucoepidermoid-carcinoma","urothelial"],"sections":[],"technologies":[],"targets":["ctla4"],"drugs":[],"companies":["oncoc4"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05671510","nct05446298","nct04140526","nct05682443"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"ONC-392, BNT316","modality":"monoclonal antibody","mechanism":"CTLA-4 checkpoint inhibition, in some regimens combined with pembrolizumab or Pluvicto.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gotistobart/","neighbours":{"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"mucoepidermoid-carcinoma","kind":"cancer","name":"Mucoepidermoid carcinoma","route":"/cancers/mucoepidermoid-carcinoma/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"gastric-pdl1-high","kind":"cancer","name":"PD-L1-high gastric cancer","route":"/cancers/gastric-pdl1-high/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"},{"id":"rcc","kind":"cancer","name":"Renal cell carcinoma","route":"/cancers/rcc/"},{"id":"salivary-gland","kind":"cancer","name":"Salivary gland cancers","route":"/cancers/salivary-gland/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"}],"company":[{"id":"oncoc4","kind":"company","name":"OncoC4","route":"/companies/oncoc4/"}],"trial":[{"id":"nct05446298","kind":"trial","name":"ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer","route":"/trials/nct05446298/"},{"id":"nct05682443","kind":"trial","name":"ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC","route":"/trials/nct05682443/"},{"id":"nct05671510","kind":"trial","name":"ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors","route":"/trials/nct05671510/"},{"id":"nct04140526","kind":"trial","name":"Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC","route":"/trials/nct04140526/"}]}}