Phase Ib, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

Study Identifier:
RMC-6291-101
CT.gov Identifier:
NCT06128551
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508178-27-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Bowel (Colorectal)
  • Pancreas
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18 - 125 Years
    Study Drug
  • Drug: Experimental: RMC-6291 and RMC-6236
    • Read More
  • Drug: Drug: Assigned interventions
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • - 18 years of age
    • - Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid
    • tumors not amendable to curative therapy
    • 1. Part 1. Dose Escalation: solid tumors, previously treated
    • 2. Part 2. Dose Expansion:
    • i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF)
    • inhibitors, ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve
    • to KRAS G12C (OFF) inhibitors, iii. NSCLC, previously treated with immunotherapy,
    • chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases <2
    • cm in size iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
    • - ECOG performance status 0 or 1
    • - Adequate organ function
    Exclusion criteria
    • - Primary central nervous system (CNS) tumors
    • - Active brain metastases
    • - Known impairment of GI function that would alter the absorption
    • - Major surgical procedures within 28 days or non-study related minor procedures within
    • 7 days of treatment

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas