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Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
START Midwest
RECRUITING
Grand Rapids
Texas
NEXT - Dallas
RECRUITING
Dallas
NEXT
RECRUITING
San Antonio
START - San Antonio
RECRUITING
San Antonio
Virginia
NEXT - Virginia
RECRUITING
Fairfax
Contact Information
Primary
Revolution Medicines Study Director
medinfo@revmed.com
1-844-2-REVMED
Time Frame
Start Date: 2026-01-08
Estimated Completion Date: 2028-10
Participants
Target number of participants: 574
Treatments
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
Sponsors
Leads: Revolution Medicines, Inc.

This content was sourced from clinicaltrials.gov

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