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Phase 1Recruiting

Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Sponsored by Revolution Medicines, Inc.

About this study

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose \[RP2D\] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).

Where this study is enrolling

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas

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Who can participate

Inclusion criteria

  • ✓Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).
  • ✓Treatment naive or have received prior standard therapy appropriate for tumor type and stage
  • ✓Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • ✓Adequate organ function

Exclusion criteria

  • ✕Primary central nervous system (CNS) tumors
  • ✕Active, untreated brain metastases
  • ✕Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • ✕History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
  • ✕Other inclusion/exclusion criteria may apply.

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Trial data sourced from ClinicalTrials.gov.