{"id":"amg-510","safety":{"commonSideEffects":[{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":{"chemblId":"CHEMBL2109249","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"AMG 510 binds covalently to the mutant KRAS G12C protein in its inactive GDP-bound state, preventing its activation and downstream signaling through the MAPK and PI3K pathways. This mechanism is specific to tumors harboring the KRAS G12C mutation, which is found in approximately 3-4% of human cancers. By selectively inhibiting this driver mutation, the drug can induce tumor regression in KRAS G12C-dependent malignancies.","oneSentence":"AMG 510 is a small-molecule inhibitor that selectively targets KRAS G12C mutations, blocking oncogenic signaling in cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:01:09.104Z","_scrapedBy":"cloudflare-swarm","_wikipedia":{"url":"https://en.wikipedia.org/wiki/Sotorasib","title":"Sotorasib","extract":"Sotorasib, sold under the brand names Lumakras and Lumykras, is an anti-cancer medication used to treat non-small-cell lung cancer. It targets a specific mutation, G12C, in the protein K-Ras encoded by gene KRAS which is responsible for various forms of cancer. Sotorasib is an inhibitor of the RAS GTPase family."},"indications":{"approved":[{"name":"Non-small cell lung cancer with KRAS G12C mutation"},{"name":"Colorectal cancer with KRAS G12C mutation"},{"name":"Pancreatic cancer with KRAS G12C mutation"}]},"trialDetails":[{"nctId":"NCT05564377","phase":"PHASE2","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2023-04-07","conditions":"Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8","enrollment":2900},{"nctId":"NCT04303780","phase":"PHASE3","title":"Study to Compare AMG 510 \"Proposed INN Sotorasib\" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).","status":"ACTIVE_NOT_RECRUITING","sponsor":"Amgen","startDate":"2020-06-04","conditions":"KRAS p, G12c Mutated /Advanced Metastatic NSCLC","enrollment":345},{"nctId":"NCT07172919","phase":"PHASE2","title":"A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation","status":"RECRUITING","sponsor":"Amgen","startDate":"2026-01-02","conditions":"Advanced Solid Tumors","enrollment":14},{"nctId":"NCT07012031","phase":"PHASE1, PHASE2","title":"Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-08-07","conditions":"Locally Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8","enrollment":37},{"nctId":"NCT05638295","phase":"PHASE2","title":"Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-08-01","conditions":"Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm","enrollment":105},{"nctId":"NCT04380753","phase":"PHASE1","title":"AMG 510 Ethnic Sensitivity Study (CodeBreaK 105).","status":"COMPLETED","sponsor":"Amgen","startDate":"2020-04-28","conditions":"Advanced/Metastatic Solid Tumors With KRAS p.G12C Mutation","enrollment":12},{"nctId":"NCT06252649","phase":"PHASE3","title":"Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","status":"RECRUITING","sponsor":"Amgen","startDate":"2024-07-17","conditions":"Metastatic Colorectal Cancer","enrollment":450},{"nctId":"NCT03600883","phase":"PHASE1, PHASE2","title":"A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid 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Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"Verastem, Inc.","startDate":"2022-04-12","conditions":"Non Small Cell Lung Cancer, KRAS Activating Mutation","enrollment":153},{"nctId":"NCT05054725","phase":"PHASE2","title":"Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies","status":"COMPLETED","sponsor":"Revolution Medicines, Inc.","startDate":"2021-12-30","conditions":"Non-Small Cell Lung Cancer","enrollment":47},{"nctId":"NCT04625647","phase":"PHASE2","title":"Testing the Use of Targeted Treatment (AMG 510) for KRAS G12C Mutated Advanced Non-squamous Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)","status":"ACTIVE_NOT_RECRUITING","sponsor":"SWOG Cancer Research Network","startDate":"2021-04-16","conditions":"Lung Adenocarcinoma, Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Squamous Non-Small Cell Carcinoma","enrollment":116},{"nctId":"NCT04933695","phase":"PHASE2","title":"A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment","status":"COMPLETED","sponsor":"Amgen","startDate":"2022-01-28","conditions":"Non-small Cell Lung Cancer","enrollment":42},{"nctId":"NCT05118854","phase":"PHASE2","title":"A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-03-30","conditions":"Lung Cancer","enrollment":27},{"nctId":"NCT07143513","phase":"","title":"Real World Evaluation of Sotorasib Among Chinese Non-Small Cell Lung Cancer Patients","status":"RECRUITING","sponsor":"Amgen","startDate":"2025-08-11","conditions":"Non-Small Cell Lung Cancer","enrollment":115},{"nctId":"NCT04667234","phase":"","title":"Expanded Access of Sotorasib","status":"NO_LONGER_AVAILABLE","sponsor":"Amgen","startDate":"","conditions":"Non Small-cell Lung Cancer, Locally Advanced Unresectable NSCLC, Locally Advanced Metastatic NSCLC","enrollment":""},{"nctId":"NCT06249282","phase":"PHASE1","title":"Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer","status":"RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2024-04-24","conditions":"Advanced Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8","enrollment":15},{"nctId":"NCT06807619","phase":"PHASE1","title":"A Study of Sotorasib in People With Brain Tumors","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2025-01-29","conditions":"Brain 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Participants","enrollment":13}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":71,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Sotorasib","Lumakras (US)","Lumykras (UK)"],"phase":"phase_3","status":"active","brandName":"AMG 510","genericName":"AMG 510","companyName":"Criterium, Inc.","companyId":"criterium-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"AMG 510 is a small-molecule inhibitor that selectively targets KRAS G12C mutations, blocking oncogenic signaling in cancer cells. Used for Non-small cell lung cancer with KRAS G12C mutation, Colorectal cancer with KRAS G12C mutation, Pancreatic cancer with KRAS G12C mutation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":3,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}