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Clinical trial · no report yet · Phase 1

NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
X threads27
Podcasts11
YouTube9

The trial

ClinicalTrials.gov
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)
Phase
Phase 1
Status
Active not recruiting
Conditions
Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Interventions
Sotorasib; Trametinib; RMC-4630; Afatinib; Pembrolizumab; Panitumumab; Carboplatin, pemetrexed, docetaxel, paclitaxel; Atezolizumab; Palbociclib; MVASI® (bevacizumab-awwb); TNO155; IV Chemotherapy (Regimen 1); IV Chemotherapy (Regimen 2); BI 1701963; AMG 404; Everolimus
Arms
  • Sotorasib + trametinib + panitumumab · Experimental
  • Sotorasib + RMC-4630 · Experimental
  • Sotorasib + afatinib · Experimental
  • Sotorasib + panitumumab +/- chemotherapy · Experimental
  • Sotorasib + atezolizumab · Experimental
  • Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab · Experimental
  • Sotorasib Monotherapy · Experimental
  • Sotorasib + palbociclib · Experimental
  • Sotorasib + pembrolizumab · Experimental
  • Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy · Experimental
  • Sotorasib + TNO155 · Experimental
  • Sotorasib + BI 1701963 · Experimental
  • Sotorasib + AMG 404 · Experimental
  • Sotorasib + everolimus · Experimental
Enrollment
610
Primary outcomes
  • Number of Participants with Dose Limiting Toxicities (DLTs)
  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)
  • Number of Participants with Treatment-related Adverse Events
  • Number of Participants with Clinically Significant Changes in Vital Signs
  • Number of Participants with Clinically Significant Changes in ECG Measurements
  • Number of Participants with Clinically Significant Changes in Laboratory Test Values
Sponsor
Amgen
Start
Dec 17, 2019
Primary completion
Dec 17, 2026 (estimated)
Results posted
No
Registry record
NCT04185883 · updated Oct 22, 2025

Publications

linked from the registry
  • 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. PubMed 38177853