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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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)

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.
Miscellaneous, Phase I
Phase I/II
Adults
Mol. targeted/Immunotherapy/Biologics
AMG 510, MK-3475, Pembrolizumab (MK-3475)
Iams, Wade
International
Vanderbilt University
06-20-2019
Treatment
VICCPHI18161
NCT03600883

Eligibility

18 Years
BOTH
NO
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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