AMG 510 for colorectal or non-small-cell lung cancer with KRAS p.G12C mutation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if a new study drug, AMG 510, for colorectal cancer patients with a specific genetic mutation is safe and if your body can handle the potential side effects.

We will also try to find what dose of the study drug is safe for patients to take.

What is the Condition Being Studied?

Colorectal Cancer and Non-Small cell Lung Cancer

Who Can Participate in the Study?

Adults who:
-Have colorectal or non-small cell lung cancer with a documented KRAS p.G12C mutation
- Are considered non-small cell lung cancer patients (you must have had prior treatment with platinum-based combination therapy and/or targeted therapies)
-Are considered colorectal cancer participants (you must have had prior treatment with 2 prior systemic therapies)

Age Group

What is Involved?

If you choose to join this study, you will:
- Take the study drug, AMG 510, by mouth, once a day
--The study drug regimen will be given in 3 week cycles
--During each cycle, you will need to visit the clinic 5 times during the first cycle, 2 times during the second cycle, and once per cycle for all the remaining cycles
-The cycles of the study drug regimen that you will receive will depend on the side effects that you get
-During your clinic visits blood samples and other procedures will be performed

Study Details

Full Title
[20170543] 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)
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00100212
NCT: NCT03600883
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center