Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
NCT ID: NCT07349537
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
574 participants
INTERVENTIONAL
2026-01-08
2028-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: RMC-5127 Monotherapy
Dose Escalation and Dose Expansion
RMC-5127
oral tablets
Arm B: RMC-5127 + Daraxonrasib Combination
Dose Escalation and Dose Expansion
RMC-5127
oral tablets
daraxonrasib
oral tablets
Arm C: RMC-5127 + Cetuximab Combination
Dose Escalation and Dose Expansion
RMC-5127
oral tablets
cetuximab
IV infusion
Interventions
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RMC-5127
oral tablets
daraxonrasib
oral tablets
cetuximab
IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Locations
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START Midwest
Grand Rapids, Michigan, United States
NEXT - Dallas
Dallas, Texas, United States
NEXT
San Antonio, Texas, United States
START - San Antonio
San Antonio, Texas, United States
NEXT - Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RMC-5127-001
Identifier Type: -
Identifier Source: org_study_id
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