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-FJD
CT.gov Identifier:
NCT06128551
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
2023-508178-27-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

Considering participating in a START clinical trial?

Get Started

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

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

    View Study Information

    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas