Ovarian Cancer Clinical Trial

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Summary

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.

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Full Description

This is an open-label, multicenter, Phase 1/1b study of RMC-6291 monotherapy in subjects with advanced KRASG12C-mutant solid tumors. The study will include 2 components: a Dose-Escalation and a Dose-Expansion. Subjects will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Other inclusion/exclusion criteria may apply.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

117

Study ID:

NCT05462717

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 16 Locations for this study

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Highlands Oncology Group
Springdale Arkansas, 72762, United States
UC Irvine Cancer Center
Orange California, 92868, United States
UC Davis Cancer Center
Sacramento California, 95817, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
MSK Cancer Center
New York New York, 10021, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Next Oncology
San Antonio Texas, 78229, United States
START
San Antonio Texas, 78229, United States
Next Oncology Virginia
Fairfax Virginia, 22031, United States
ICO
Angers , 49055, France
Centre Oscar Lambret
Lille , 59000, France
ICANS
Strasbourg , 67200, France
Med - Polonia Sp. z o. o.
Poznań , 60-69, Poland
Instytut MSF Sp zoo
Łódź , 90-30, Poland

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

117

Study ID:

NCT05462717

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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