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)
- 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?
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
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 ACCRUAL