Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Revolution Medicines, Inc.
Study ID
NCT07349537
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RMC-5127 — DRUG
    oral tablets
  • daraxonrasib — DRUG
    oral tablets
  • cetuximab — DRUG
    IV infusion

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Jan 8, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
574 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Number of patients with adverse events (AEs) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Yale Cancer CenterNew HavenConnecticut06511
Ingrid Palma
[email protected]
203-833-1034
Johns HopkinsBaltimoreMaryland21231
Katelyn Spence
[email protected]
443-927-1685
Dana-Farber Cancer InstituteBostonMassachusetts02215
Kailene Sullivan
[email protected]
617-632-3482
START MidwestGrand RapidsMichigan49546
[email protected]
616-954-5554
Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Salman Punekar
[email protected]
212-731-6228
NEXT - DallasDallasTexas75039
NEXT TXReferrels
[email protected]
972-893-8800
NEXTSan AntonioTexas78229
Jordan Georg
[email protected]
210-580-9521
START - San AntonioSan AntonioTexas78229
Isabel Jimenez
[email protected]
210-593-5265
NEXT - VirginiaFairfaxVirginia22031
Paolo Umayam
[email protected]
703-783-4546

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Yale Cancer Center· New Haven, CTJohns Hopkins· Baltimore, MDDana-Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MILaura and Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NYNEXT - Dallas· Dallas, TX

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