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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 (9) 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
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins
RECRUITING
Baltimore
Michigan
START Midwest
RECRUITING
Grand Rapids
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITING
New York
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
Related Therapeutic Areas
Lung Cancer
Colorectal Cancer
Non-Small Cell Lung Cancer (NSCLC)
Pancreatic Cancer
Sponsors
Leads: Revolution Medicines, Inc.

This content was sourced from clinicaltrials.gov

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