Phase I/IB, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors
Details
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
Eligibility
You can join if...
AM I ELIGIBLE TO PARTICIPATE IN THIS STUDY?
Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; your study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study.
Inclusion Requirements
You can participate in this study if you :
must be > or = 18 years of age.
must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
ECOG performance status 0 or 1
Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
Adequate organ function
Exclusion Requirements
You cannot participate in this study if you:
Have primary central nervous system (CNS) tumors
Have active brain metastases
Have known impairment of GI function that would alter the absorption
Have major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
Have prior therapy with KRASG12C (ON) inhibitor
Other inclusion/exclusion criteria may apply.