{"id":"mrtx849","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Diarrhea"},{"rate":"30-40","effect":"Nausea"},{"rate":"25-35","effect":"Fatigue"},{"rate":"20-30","effect":"Vomiting"},{"rate":"15-25","effect":"Abdominal pain"},{"rate":"10-20","effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"MRTX849 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 selective for the G12C mutation, which occurs in approximately 10-15% of non-small cell lung cancers and other solid tumors. By locking KRAS in its inactive state, the drug inhibits tumor cell proliferation and survival.","oneSentence":"MRTX849 is a small-molecule inhibitor that selectively targets KRAS G12C mutations, blocking oncogenic signaling in cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:50:14.023Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"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":"NCT05853575","phase":"PHASE2","title":"Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mirati Therapeutics Inc.","startDate":"2024-02-16","conditions":"Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung","enrollment":200},{"nctId":"NCT07288034","phase":"PHASE2","title":"Immunotherapy Biomarkers to Predict First-line PD(L)1-based Immunotherapy Response and Selection of Second-line Treatment in Stage IIIB-IV Non-small Cell Lung Cancer, IMMUNO-BIOMAP Trial","status":"NOT_YET_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2026-09-21","conditions":"Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8","enrollment":535},{"nctId":"NCT03994796","phase":"PHASE2","title":"Genetic Testing in Guiding Treatment for Patients With Brain Metastases","status":"SUSPENDED","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2019-10-17","conditions":"CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm","enrollment":186},{"nctId":"NCT05722327","phase":"PHASE1","title":"Phase I Trial of Adagrasib (MRTX849) in Combination With Cetuximab and Irinotecan in Patients With Colorectal Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2023-12-06","conditions":"Colon Cancer, Colorectal Cancer","enrollment":24},{"nctId":"NCT05578092","phase":"PHASE1","title":"A Phase 1 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway","status":"TERMINATED","sponsor":"Mirati Therapeutics Inc.","startDate":"2022-12-02","conditions":"Solid Tumor, Advanced Solid Tumor, Non Small Cell Lung Cancer","enrollment":64},{"nctId":"NCT06764771","phase":"PHASE1","title":"A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Bristol-Myers Squibb","startDate":"2025-03-25","conditions":"Advanced Malignant Tumors","enrollment":437},{"nctId":"NCT06130254","phase":"PHASE1","title":"Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2024-01-30","conditions":"Advanced Solid Tumor, Non-small Cell Lung Cancers","enrollment":52},{"nctId":"NCT03785249","phase":"PHASE1, PHASE2","title":"Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mirati Therapeutics Inc.","startDate":"2019-01-15","conditions":"Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease","enrollment":731},{"nctId":"NCT05472623","phase":"PHASE2","title":"Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab","status":"WITHDRAWN","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","startDate":"2023-03-21","conditions":"Resectable Non-Small Cell Lung Cancer","enrollment":""},{"nctId":"NCT05162443","phase":"","title":"Expanded Access of Adagrasib (MRTX849) in Patients With Advanced Solid Tumors Who Have a KRAS G12C Mutation","status":"APPROVED_FOR_MARKETING","sponsor":"Bristol-Myers Squibb","startDate":"","conditions":"Advanced Cancer, Metastatic Cancer, Malignant Neoplasm","enrollment":""},{"nctId":"NCT05634525","phase":"PHASE1","title":"Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients","status":"WITHDRAWN","sponsor":"M.D. Anderson Cancer Center","startDate":"2023-05-03","conditions":"Metastatic Pancreatic Cancer","enrollment":""},{"nctId":"NCT06024174","phase":"PHASE1, PHASE2","title":"A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors","status":"TERMINATED","sponsor":"Bristol-Myers Squibb","startDate":"2023-11-09","conditions":"Advanced Solid Tumors","enrollment":5},{"nctId":"NCT06801418","phase":"PHASE1","title":"Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets","status":"COMPLETED","sponsor":"Mirati Therapeutics Inc.","startDate":"2025-02-04","conditions":"Healthy Volunteers","enrollment":160},{"nctId":"NCT05840510","phase":"PHASE1","title":"Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)","status":"TERMINATED","sponsor":"Mirati Therapeutics Inc.","startDate":"2023-08-07","conditions":"Solid Tumor, Adult, NSCLC, Advanced Cancer","enrollment":6},{"nctId":"NCT04330664","phase":"PHASE1","title":"Adagrasib in Combination With TNO155 in Patients With Cancer (KRYSTAL 2)","status":"COMPLETED","sponsor":"Mirati Therapeutics Inc.","startDate":"2020-04-07","conditions":"Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease","enrollment":86},{"nctId":"NCT04793958","phase":"PHASE3","title":"Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mirati Therapeutics Inc.","startDate":"2021-06-24","conditions":"Advanced Colorectal Cancer, Metastatic Colorectal Cancer","enrollment":461},{"nctId":"NCT05178888","phase":"PHASE1","title":"Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)","status":"COMPLETED","sponsor":"Mirati Therapeutics Inc.","startDate":"2022-01-20","conditions":"Advanced Solid Tumor","enrollment":11},{"nctId":"NCT04685135","phase":"PHASE3","title":"Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","status":"ACTIVE_NOT_RECRUITING","sponsor":"Mirati Therapeutics Inc.","startDate":"2021-02-23","conditions":"Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer","enrollment":453},{"nctId":"NCT04975256","phase":"PHASE1","title":"Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)","status":"TERMINATED","sponsor":"Mirati Therapeutics Inc.","startDate":"2021-07-28","conditions":"Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Colon","enrollment":7},{"nctId":"NCT05263986","phase":"PHASE1","title":"The Clinical Trial to Evaluate the Pharmacokinetics and Safety of MRTX849 in Patients With Advanced Solid Tumors","status":"UNKNOWN","sponsor":"Zai Lab (Shanghai) Co., Ltd.","startDate":"2022-05-30","conditions":"Advanced or Metastatic Solid Tumor","enrollment":22}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":84,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["adagrasib","Adagrasib","KRAZATI","KRAS G12C","adagrasib (KRAZATI)"],"phase":"phase_3","status":"active","brandName":"MRTX849","genericName":"MRTX849","companyName":"Mirati Therapeutics Inc.","companyId":"mirati-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"MRTX849 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":1,"trialStats":{"total":5,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}