Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study includes two components: a Dose Escalation part and a Dose Expansion part.
In the Dose Escalation part, participants will receive escalating dose levels of the study drug (RMC-6291), which is administered as an oral tablet once or twice a day, to identify the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).
In the Dose Expansion part, the safety and effectiveness of RMC-6291 will further be studied.
Conditions
This trial is treating patients with advanced solid cancers
Eligibility
Inclusion
- Subject must be ≥18 years of age.
- Subject 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
- Primary central nervous system (CNS) tumors
- Active brain metastases
- Known impairment of GI function that would alter the absorption
- Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
- Prior therapy with KRASG12C (ON) inhibitor
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Revolution Medicines, Inc.
Scientific Title
Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
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