Recruiting
Phase 1
Phase 2

RMC-6291 & RMC-6236

Sponsor:

Revolution Medicines, Inc.

Code:

NCT06128551

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Colorectal Cancer

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elironrasib

Daraxonrasib

Study Details

Brief summary:

This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Colorectal Cancer

Pancreatic Ductal Adenocarcinoma

Study ID

NCT06128551

Start date

Nov 14, 2023

Status verified date

Jul, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age
  • Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

1. Phase 1b Dose Escalation: solid tumors, previously treated
2. Phase 1b Dose Expansion and Phase 2:

i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
  • ECOG performance status 0 or 1
  • 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

Study Design

Enrollment

534 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Elironrasib Monotherapy

Phase 2 only

experimental: Daraxonrasib Monotherapy

Phase 2 only

experimental: Daraxonrasib + Elironrasib Combination

Phase 1b and 2

Interventions

Elironrasib

oral tablets

Daraxonrasib

oral tablets

Primary outcome measure

  • Number of patients with adverse events (AEs) in Phase 1b [ Time Frame: Up to approximately 3 years ]
  • Changes in vital signs in Phase 1b [ Time Frame: Up to approximately 3 years ]
  • Changes in clinical laboratory test values in Phase 1b [ Time Frame: Up to approximately 3 years ]
  • Dose Limiting Toxicities in Phase 1b [ Time Frame: 21 days ]
  • Changes in ECGs in Phase 1b [ Time Frame: Up to approximately 3 years ]
  • Overall Response Rate (ORR) in Phase 2 [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Revolution Medicines, Inc.

1-844-2-REVMEDmedinfo@revmed.com

Locations

UC IRVINE Health

Recruiting

Orange, California, United States, 92868

UC Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Stanford Cancer Institute

Recruiting

Stanford, California, United States, 94305

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

Moffitt Cancer Center and Research Institute

Recruiting

Tampa, Florida, United States, 33612

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46250

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Columbia University

Recruiting

New York, New York, United States, 10032

NYU Langone Health

Recruiting

New York, New York, United States, 10032

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Allegheny Health Network

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Sarah Cannon Research Institue

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson

Recruiting

Houston, Texas, United States, 77030

NEXT Dallas

Recruiting

Irving, Texas, United States, 75039

NEXT Oncology San Antonio

Recruiting

San Antonio, Texas, United States, 78229

START Texas

Recruiting

San Antonio, Texas, United States, 78229

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • RMC-6291
  • RAS (ON)
  • KRAS
  • KRASG12C
  • KRASG12C (ON)
  • Targeted therapy
  • Metastatic Cancer
  • Lung Cancer
  • Lung Neoplasms
  • Thoracic Neoplasms
  • Non-small Cell Lung Cancer
  • Carcinoma, Non-Small Cell Lung
  • NSCLC
  • Colorectal Cancer
  • Colonic Neoplasms
  • CRC
  • Appendiceal Cancer
  • KRAS mutation
  • STK11/LKB1
  • KEAP1
  • Bronchial neoplasms
  • Respiratory tract neoplasms
  • Neoplasms by site
  • Neoplasms
  • Colon Cancer
  • Rectal Cancer
  • Lung disease
  • Respiratory tract diseases
  • Pancreatic Cancer
  • Carcinoma, Pancreatic Ductal
  • PDAC
  • Gastrointestinal Neoplasms
  • Intestinal Neoplasms
  • Esophageal Cancer
  • Ampullary Cancer
  • Gastric Cancer
  • Gynecological Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • RMC-6236
  • Elironrasib
  • Daraxonrasib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Revolution Medicines, Inc. on 2026-08-03.