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

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.

Interventions

• RMC-5127 · DRUG

  oral tablets

• daraxonrasib · DRUG

  oral tablets

• cetuximab · DRUG

  IV infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (9)

• Yale Cancer Center, New Haven, Connecticut · RECRUITING
• Johns Hopkins, Baltimore, Maryland · RECRUITING
• Dana-Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• START Midwest, Grand Rapids, Michigan · RECRUITING
• Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York · RECRUITING
• NEXT - Dallas, Dallas, Texas · RECRUITING
• NEXT, San Antonio, Texas · RECRUITING
• START - San Antonio, San Antonio, Texas · RECRUITING
• NEXT - Virginia, Fairfax, Virginia · RECRUITING