Clinical Trial 22002

• Overview

  Study Title:

  A Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in RAS

  Summary:

  Phase 1/1b, 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).

  Objective:

  Primary * To evaluate the safety and tolerability of RMC-6236 monotherapy in adult subjects with advanced solid tumors harboring KRASG12X mutations, excluding KRASG12C * To define the MTD and/or RP2DS for RMC-6236 monotherapy in adult subjects with advanced solid tumors harboring KRASG12X mutations, excluding KRASG12C Secondary * To characterize the whole blood PK of RMC-6236 * To evaluate the preliminary antitumor effects of RMC-6236 monotherapy in subjects with advanced solid tumors harboring KRASG12X mutations, excluding KRASG12C * To evaluate the effect of food on the PK of RMC-6236 monotherapy

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  RMC-6236 ()

• Inclusion Criteria

  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.
  • 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
  • Other criteria may apply

• Exclusion Criteria

  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 criteria may apply

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