A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

Last updated: May 30, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Treatment

Phase I Arm B

Phase I Arm A

Clinical Study ID

NCT06619587
GO45416
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation

  • Agreement to adhere to the contraception requirements described in the protocol forparticipants of childbearing potential and participants who produce sperm

Exclusion

Exclusion criteria:

  • Malabsorption or other condition that would interfere with enteral absorption

  • Active brain metastases

  • Clinically significant cardiovascular dysfunction or liver disease

Study Design

Total Participants: 410
Treatment Group(s): 2
Primary Treatment: Phase I Arm B
Phase: 1
Study Start date:
November 14, 2024
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1X6
    Canada

    Active - Recruiting

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv-Yafo, 6423906
    Israel

    Active - Recruiting

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona, 08035
    Spain

    Active - Recruiting

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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