AMG 510 in Advanced Solid Tumors With KRAS p.G12C Mutation - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how an experimental drug called sotorasib works in your body and against your cancer. We will compare how this drug works alone and in combination with several different drugs.

What is the Condition Being Studied?

Advanced solid tumors with KRAS p.G12C mutations

Who Can Participate in the Study?

Adults who:
- Have metastatic cancer with confirmed KRAS p.G12C mutation
- Are able to swallow pills
- Do not have a primary brain tumor (treated brain metastases are okay)

Age Group
Adults

What is Involved?

This study has 2 parts: a screening period and a study dosing period.

If you choose to join this study, during the screening period you will:
- Have tests done in our clinic to see if you're eligible
- Have a tumor biopsy done, if necessary

If you're eligible for the dosing period, you will:
- Take the study drug (sotorasib) alone or in combination with other drugs, which will depend on the type of cancer you have
- Have physical exams
- Have blood draws
- Have other tests done during your clinic visits

Study Details

Full Title
A Phase 1b, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00104161
NCT: NCT04185883
Phase
Phase I
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698