A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation

Study Identifier:
GO45416
CT.gov Identifier:
NCT06619587
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-515144-23-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

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.
  • 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
  • Drug: Experimental: Phase I Arm A
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  • Drug: Intervention/Treatment
  • Drug: Experimental: Phase I Arm B
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
    • * Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
    Exclusion criteria
    • Exclusion criteria:
    • * Malabsorption or other condition that would interfere with enteral absorption
    • * Active brain metastases
    • * Clinically significant cardiovascular dysfunction or liver disease

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor