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Trial Summary


Protocol No.20170543
StatusOPEN TO ACCRUAL
Principal InvestigatorDurm, Greg
ScopeNational
PhasePhase I/II
Age GroupAdult
TitleA Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreak 100).
DescriptionEvaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant solid tumors. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose [RP2D]) within investigated subject population groups.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures Men or women greater than or equal to 18 years old Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through DNA sequencing. Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.
  • Part 1 (Dose Exploration) - Subjects willing to provide archived tumor samples (fresh frozen sample or formalin fixed, paraffin embedded [FFPE] sample collected within 5 years) or willing to undergo pretreatment tumor biopsy.
  • Part 2 (Dose Expansion) - Willing to undergo pre-treatment tumor biopsy. Subjects can be allowed to enroll without undergoing tumor biopsy upon agreement with Investigator and the Medical Monitor if tumor biopsy is not feasible.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesAny Site
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu