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

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

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

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

No

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

John
Strickler

Protocol Number

PRO00104161

NCT ID

NCT04185883

Phase

I

Enrollment Status

Open to Enrollment
ClinicalTrials.gov