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Evaluating sotorasib for advanced solid tumors with KRAS p.G12C mutation

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)

PHASE1 · Amgen · NCT04185883

This study is testing a new drug called sotorasib, along with other treatments, to see if it can help adults with advanced solid tumors that have a specific KRAS mutation.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment1200 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorAmgen (industry)
Locations90 sites (Tucson, Arizona and 89 other locations)
Trial IDNCT04185883 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and tolerability of sotorasib in adult patients with advanced solid tumors harboring the KRAS p.G12C mutation. Participants will receive sotorasib along with other investigational treatments such as Trametinib, RMC-4630, Afatinib, and Pembrolizumab. The study will involve molecular testing to confirm the presence of the KRAS mutation, ensuring that only eligible patients are enrolled. The trial is designed to gather data on the effectiveness of these treatments in managing advanced malignancies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with pathologically documented advanced solid tumors that have the KRAS p.G12C mutation.

Not a fit: Patients with primary brain tumors, untreated symptomatic brain metastases, or significant gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new targeted treatment option for patients with advanced solid tumors that have the KRAS p.G12C mutation.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria:

* Primary brain tumor.
* Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Where this trial is running

Tucson, Arizona and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Advanced Solid Tumors, Kirsten Rat Sarcoma pG12C Mutation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.