{"commentary":{"count":47,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":27,"podcast":11,"youtube":9},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04185883\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"NCT04185883","nct_id":"NCT04185883","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct04185883. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.","label":"Sotorasib + trametinib + panitumumab","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.","label":"Sotorasib + RMC-4630","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.","label":"Sotorasib + afatinib","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.","label":"Sotorasib + panitumumab +/- chemotherapy","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.","label":"Sotorasib + atezolizumab","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.","label":"Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib only Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.","label":"Sotorasib Monotherapy","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.","label":"Sotorasib + palbociclib","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.","label":"Sotorasib + pembrolizumab","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.","label":"Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.\n* Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.","label":"Sotorasib + TNO155","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion\n\n* Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors.\n* Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.","label":"Sotorasib + BI 1701963","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors","label":"Sotorasib + AMG 404","type":"EXPERIMENTAL"},{"description":"Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.","label":"Sotorasib + everolimus","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12-05","type":"ESTIMATED"},"conditions":["Advanced Solid Tumors","Kirsten Rat Sarcoma (KRAS) pG12C Mutation"],"enrollment":{"count":610,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Sotorasib","type":"DRUG"},{"name":"Trametinib","type":"DRUG"},{"name":"RMC-4630","type":"DRUG"},{"name":"Afatinib","type":"DRUG"},{"name":"Pembrolizumab","type":"DRUG"},{"name":"Panitumumab","type":"DRUG"},{"name":"Carboplatin, pemetrexed, docetaxel, paclitaxel","type":"DRUG"},{"name":"Atezolizumab","type":"DRUG"},{"name":"Palbociclib","type":"DRUG"},{"name":"MVASI® (bevacizumab-awwb)","type":"DRUG"},{"name":"TNO155","type":"DRUG"},{"name":"IV Chemotherapy (Regimen 1)","type":"DRUG"},{"name":"IV Chemotherapy (Regimen 2)","type":"DRUG"},{"name":"BI 1701963","type":"DRUG"},{"name":"AMG 404","type":"DRUG"},{"name":"Everolimus","type":"DRUG"}],"last_update":"2025-10-22","lead_sponsor":"Amgen","official_title":"A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2026-12-17","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of Participants with Dose Limiting Toxicities (DLTs)","timeFrame":"12 Months"},{"measure":"Number of Participants with Treatment-emergent Adverse Events (TEAEs)","timeFrame":"12 Months"},{"measure":"Number of Participants with Treatment-related Adverse Events","timeFrame":"12 Months"},{"measure":"Number of Participants with Clinically Significant Changes in Vital Signs","timeFrame":"12 Months"},{"measure":"Number of Participants with Clinically Significant Changes in ECG Measurements","timeFrame":"12 Months"},{"measure":"Number of Participants with Clinically Significant Changes in Laboratory Test Values","timeFrame":"12 Months"}],"references":[{"citation":"Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4.","pmid":"38177853","type":"BACKGROUND"}],"start_date":{"date":"2019-12-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)","url":"https://clinicaltrials.gov/study/NCT04185883"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct04185883"}