Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
NCT05462717 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 222
Last updated 2026-05-15
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.
Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Colorectal Cancer (CRC)
- Pancreatic Ductal Adenocarcinoma
- Advanced Solid Tumor
Interventions
- DRUG
-
RMC-6291
Oral tablet once or twice a day
Sponsors & Collaborators
-
Revolution Medicines, Inc.
lead INDUSTRY
Principal Investigators
-
Revolution Medicines, Inc. · Revolution Medicines, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-19
- Primary Completion
- 2027-03-31
- Completion
- 2027-09-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Czechia
- France
- Italy
- Malaysia
- Poland
- Serbia
- Singapore
- South Korea
- Spain
- Taiwan
- Thailand
Study Locations
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