Recruiting
Phase 1

RMC-5127, Daraxonrasib, Cetuximab

Sponsor:

Revolution Medicines, Inc.

Code:

NCT07349537

Conditions

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

PDAC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RMC-5127

daraxonrasib

cetuximab

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Colorectal Cancer (CRC)

Pancreatic Adenocarcinoma

Pancreatic Ductal Adenocarcinoma (PDAC)

PDAC

Study ID

NCT07349537

Start date

Jan 8, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
  • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
  • Measurable per RECIST v1.1
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

Exclusion Criteria:

  • Primary central nervous system (CNS) tumors
  • Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • Any conditions that may affect the ability to take or absorb study drug.
  • Major surgery within 28 days prior to receiving study drug(s).
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Study Design

Enrollment

574 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: RMC-5127 Monotherapy

Dose Escalation and Dose Expansion

experimental: Arm B: RMC-5127 + Daraxonrasib Combination

Dose Escalation and Dose Expansion

experimental: Arm C: RMC-5127 + Cetuximab Combination

Dose Escalation and Dose Expansion

Interventions

RMC-5127

oral tablets

daraxonrasib

oral tablets

cetuximab

IV infusion

Primary outcome measure

  • Number of patients with adverse events (AEs) [ Time Frame: Up to approximately 3 years ]
  • Changes in vital signs [ Time Frame: Up to approximately 3 years ]
  • Changes in electrocardiogram (ECG) test values [ Time Frame: Up to approximately 3 years ]
  • Changes in clinical laboratory test values [ Time Frame: Up to approximately 3 years ]
  • Dose Limiting Toxicities [ Time Frame: Up to 28 days ]

Central Contacts and Locations

Central contacts

Revolution Medicines Study Director

1-844-2-REVMEDmedinfo@revmed.com

Locations

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Ingrid Palma

203-833-1034ingrid.palma@yale.edu

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Katelyn Spence

443-927-1685kspenc29@jh.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Kailene Sullivan

617-632-3482kailene_sullivan@dfci.harvard.edu

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

616-954-5554hopeteam@startresearch.com

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Salman Punekar

212-731-6228salman.punekar@nyulangone.org

NEXT - Dallas

Recruiting

Dallas, Texas, United States, 75039

Contacts

NEXT TXReferrels

972-893-8800NXT_TXReferrals@nextoncology.com

NEXT

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

210-580-9521jgeorg@nextoncology.com

START - San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez

210-593-5265isabel.jimenez@startresearch.com

NEXT - Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Paolo Umayam

703-783-4546pumayam@nextoncology.com

More Information

Sponsor

Revolution Medicines, Inc.

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • Advanced Solid Tumors
  • Pancreatic Cancer
  • Pancreatic Ductal Adenocarcinoma
  • PDAC
  • Colorectal Cancer
  • CRC
  • Lung Cancer
  • Non-small Cell Lung Cancer
  • NSCLC
  • RAS
  • KRAS
  • RAS Mutation

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 2026-07-10.