{"entity":{"id":"nct03785249","kind":"trial","name":"Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1","aka":["KRYSTAL-1"],"tldr":"A phase 1/2 trial of Pembrolizumab, Cetuximab, Afatinib in metastatic cancer, run by Mirati Therapeutics Inc., active and no longer recruiting.","summary":"Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1 is a phase 1/2 interventional study registered as NCT03785249 by Mirati Therapeutics Inc., with 731 participants enrolled, started 2019-01-15 and due to reach its primary completion in 2026-06-23. Interventions recorded: MRTX849, Pembrolizumab, Cetuximab, Afatinib. Conditions listed: Advanced Cancer, Metastatic Cancer, Malignant Neoplastic Disease. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03785249","url":"https://clinicaltrials.gov/study/NCT03785249"},{"label":"Bekaii-Saab et al., adagrasib in advanced solid tumours harbouring a KRAS G12C mutation (JCO 2023)","url":"https://doi.org/10.1200/JCO.23.00434"}],"tags":["ctgov-ingest"],"related":[],"cancers":["metastatic-cancer","colorectal","kras-g12c-colorectal","kras-g12c-pdac","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":["pembrolizumab","cetuximab","afatinib"],"companies":["bms"],"institutions":[],"pathways":[],"terms":["kras-mutation-subtypes"],"trials":["codebreak-100"],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03785249-n-engl-j-med-2022"],"journals":[],"dependsOn":[],"notes":["KRYSTAL-1 phase 2 cohort of KRAS G12C solid tumours other than lung and colorectal cancer (JCO 2023, data cut 1 October 2022): 64 enrolled, 63 treated, median two prior lines; responses in 20 of 57 evaluable patients (35.1 percent), including 7 of 21 pancreatic (33.3 percent) and 5 of 12 biliary tract cancers; median duration of response 5.3 months, progression-free survival 7.4 months; treatment-related adverse events grade 3 to 4 in 27 percent, no discontinuations. This cohort is the NCCN basis for adagrasib in KRAS G12C pancreatic cancer; no regulator has approved the indication."],"nct":"NCT03785249","phase":"1/2","setting":"A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1","sponsor":"Mirati Therapeutics Inc.","result":"Pancreatic cancer cohort: objective response in 7 of 21 patients (33.3 percent); across the 57 evaluable non-lung, non-colorectal KRAS G12C tumours response 35.1 percent, median duration of response 5.3 months, median progression-free survival 7.4 months.","started":"2019-01-15","startedType":"actual","yearReported":2023,"enrolled":731,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response, pancreatic cancer cohort","unit":"%","arms":[{"name":"Adagrasib 600 mg twice daily","n":21,"value":33.3,"note":"7 of 21; all partial responses"}],"source":"https://doi.org/10.1200/JCO.23.00434"}]},"route":"/trials/nct03785249/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"kras-g12c-colorectal","kind":"cancer","name":"KRAS G12C-mutant colorectal cancer","route":"/cancers/kras-g12c-colorectal/"},{"id":"kras-g12c-pdac","kind":"cancer","name":"KRAS G12C-mutant pancreatic ductal adenocarcinoma","route":"/cancers/kras-g12c-pdac/"},{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"drug":[{"id":"adagrasib","kind":"drug","name":"Adagrasib","route":"/drugs/adagrasib/"},{"id":"afatinib","kind":"drug","name":"Afatinib","route":"/drugs/afatinib/"},{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}],"term":[{"id":"kras-mutation-subtypes","kind":"term","name":"KRAS mutation subtypes (G12C, G12D, G12V)","route":"/terms/kras-mutation-subtypes/"}],"trial":[{"id":"codebreak-100","kind":"trial","name":"CodeBreaK 100 (pancreatic cancer cohort)","route":"/trials/codebreak-100/"}],"paper":[{"id":"paper-nct03785249-n-engl-j-med-2022","kind":"paper","name":"Adagrasib in Non-Small-Cell Lung Cancer Harboring a KRAS G12C Mutation","route":"/key-papers/paper-nct03785249-n-engl-j-med-2022/"},{"id":"paper-krystal-1-adagrasib-kras-g12c-solid-tumours-jco-2023","kind":"paper","name":"KRYSTAL-1: adagrasib in advanced solid tumours harbouring a KRAS G12C mutation, including pancreatic cancer","route":"/key-papers/paper-krystal-1-adagrasib-kras-g12c-solid-tumours-jco-2023/"}]}}