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

Running, not enrolling · Phase 1

Conditions studied: Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT05462717

Run by

Revolution Medicines, Inc.

People needed

222

Starts

2022-09-19

Expected to finish

2027-09-30

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 and for NSCLC in dose expansion
• Adequate organ function

You may not qualify if…

• 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.

Where it is running

• Highlands Oncology Group — Springdale, Arkansas, United States
• UC Irvine Cancer Center — Orange, California, United States
• UC Davis Cancer Center — Sacramento, California, United States
• UCSF — San Francisco, California, United States
• University of Miami School of Medicine Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• American Oncology Partners of Maryland — Bethesda, Maryland, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• MSK Cancer Center — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Next Oncology — San Antonio, Texas, United States
• START — San Antonio, Texas, United States
• Next Oncology Virginia — Fairfax, Virginia, United States
• Southside Cancer Care Centre — Sydney, New South Wales, Australia
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia
• Austin Health, Olivia Newton-John Cancer Research & Wellness Centre — Heidelberg, Victoria, Australia
• South West Health Care — Warrnambool, Victoria, Australia
• NH Hospital a.s. — Hořovice, Czechia
• Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia
• Onkologicka klinika, Fakultni Nemocnice Olomouc — Olomouc, Czechia
• ICO — Angers, France
• CHU Bordeaux Hospital Saint-Andre — Bordeaux, France
• Narodowy Instytut Onkologii — Warsaw, Poland

Full record on ClinicalTrials.gov

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