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

  • STATUS
    Recruiting
  • End date
    Jan 3, 2026
  • participants needed
    1273
  • sponsor
    Amgen
Updated on 31 October 2021

Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Details
Condition Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Treatment Panitumumab, Everolimus, Pembrolizumab, Afatinib, FOLFIRI, Palbociclib, Trametinib, Atezolizumab, Loperamide, FOLFOX, TNO155, PD-1 Inhibitor, AMG 510, RMC-4630, AMG 404, PD1 inhibitor, MEK inhibitor, SHP2 allosteric inhibitor, Pan-ErbB tyrosine kinase inhibitor, Sotorasib, PD-L1 inhibitor, EGFR inhibitor, Chemotherapeutic regimen, mTOR inhibitor, mTOR inhibitor, CDK inhibitor, VEGF inhibitor, VEGF inhibitor, carboplatin, pemetrexed, docetaxel, MVASI® (bevacizumab-awwb)
Clinical Study IdentifierNCT04185883
SponsorAmgen
Last Modified on31 October 2021

Eligibility

Yes No Not Sure

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

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
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