Phase I/Ib, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors

Study Identifier:
RMC-9805-001
CT.gov Identifier:
NCT06040541
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the safety and tolerability of RMC-9805 in adults with KRAS G12D-mutant solid tumors.

To evaluate RMC-9805 in patients with advanced solid tumors harboring a KRAS G12D mutation.

To evaluate preliminary safety, pharmacokinetics, antitumor activity and circulating tumor DNA (ctDNA) changes with RMC9805, an oral, RAS(ON) G12D-selective, tri-complex inhibitor in patients with KRAS G12D pancreatic ductal adenocarcinoma (PDAC).

Antitumor activity was assessed every 6 weeks for the first 24 weeks and every 9 weeks thereafter. Additional patients were enrolled at doses that

cleared the dose-limiting toxicity (DLT) evaluation to further characterize pharmacokinetics, safety, antitumor activity and biomarkers of RMC-9805.

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
  • Solid Tumor
    • 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+ years
    Study Drug
    N/A
    Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
    • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
    • ECOG performance status 0 or 1
    • Adequate organ function
    • Participants should provide archival tumor samples collected within 5 years of C1D1
    Exclusion criteria
    • Primary central nervous system (CNS) tumors
    • Known or suspected leptomeningeal or active brain metastases or spinal cord compression
    • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
    • Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

    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
    Solid Tumor