{"entity":{"id":"setidegrasib","kind":"drug","name":"Setidegrasib","aka":[],"tldr":"Setidegrasib is an experimental investigational agent whose form is not stated in the registry from Astellas Pharma Global Development in phase 3 trials for pancreatic ductal adenocarcinoma and non-small-cell lung cancer, aimed at KRAS.","summary":"Setidegrasib (ASP3082) is an investigational agent whose form is not stated in the registry developed by Astellas Pharma Global Development. Its target is KRAS (the sponsor names KRAS G12D). The sponsor states: Setidegrasib (ASP3082) is designed to stop the action of abnormal proteins produced by the KRAS G12D mutation; given as a weekly intravenous infusion combined with mFOLFIRINOX or NALIRIFOX chemotherapy in KRAS G12D-mutated metastatic pancreatic cancer, and versus docetaxel in KRAS G12D-mutated NSCLC. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT07409272 (A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer) and NCT07566052 (A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation), in pancreatic ductal adenocarcinoma and non-small-cell lung cancer. The largest, NCT07409272, plans to enrol 614 participants with primary completion expected 2029-08-31. 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 Setidegrasib","url":"https://clinicaltrials.gov/search?intr=ASP3082"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["pancreatic","nsclc"],"sections":[],"technologies":[],"targets":["kras"],"drugs":[],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07409272","nct07566052"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["23 Sept 2026: a reviewer reports ASP3082 as a KRAS G12D-selective protein degrader that recruits the VHL E3 ligase, per its discovery paper. That paper is not in the corpus and could not be checked when this note was written, so the modality stays as the registry states it and no E3 ligase is recorded; neither this record nor the open drug engine names cereblon for it (the engine files it outside the degrader format until a sourced modality is added). Add the discovery paper as a link and set the modality to a degrader to move it into the target x E3 ligase grid."],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"ASP3082","modality":"not stated (registered as a drug or biological on ClinicalTrials.gov)","mechanism":"Setidegrasib (ASP3082) is designed to stop the action of abnormal proteins produced by the KRAS G12D mutation; given as a weekly intravenous infusion combined with mFOLFIRINOX or NALIRIFOX chemotherapy in KRAS G12D-mutated metastatic pancreatic cancer, and versus docetaxel in KRAS G12D-mutated NSCLC.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/setidegrasib/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"}],"trial":[{"id":"nct07566052","kind":"trial","name":"A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation","route":"/trials/nct07566052/"},{"id":"nct07409272","kind":"trial","name":"A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer","route":"/trials/nct07409272/"},{"id":"nct07483983","kind":"trial","name":"Study Investigating ASP3082 in Patients With Metastatic/Locally Advanced Non-small-cell Lung Cancer (NSCLC) and Pancreatic Ductal Adenocarcinoma (PDAC), With Bi","route":"/trials/nct07483983/"}]}}