A Phase 1/2 Study Evaluating the Safety Tolerability PK and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

  • STATUS
    Recruiting
  • End date
    Jan 23, 2025
  • participants needed
    733
  • sponsor
    Amgen
Updated on 24 July 2021
Investigator
Amgen Call Center
Primary Contact
Research Site (7.2 mi away) Contact
+283 other location

Summary

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Details
Condition Advanced KRAS p.G12C Mutant Solid Tumors, Advanced KRAS p.G12C Mutant Solid Tumors, Advanced KRAS p.G12C Mutant Solid Tumors, Advanced KRAS p.G12C Mutant Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors, KRAS p.G12C Mutant Advanced Solid Tumors
Treatment Midazolam, AMG 510, Anti PD-1/L1
Clinical Study IdentifierNCT03600883
SponsorAmgen
Last Modified on24 July 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

Active brain metastases 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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