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)

  • Interventional
  • Recruiting
  • NCT03600883
Eligibility Details Visit Clinicaltrials.gov

A 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)

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.

Gender
All

Age Group
18 Years to 100 Years

Accepting Healthy Volunteers?
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.

At a Glance

National Government IDNCT03600883

IRB#IRB19-1793

Lead SponsorAmgen

Lead PhysicianChristine Bestvina

Collaborator(s)N/A

EligibilityAll
18 Years to 100 Years
Recruiting