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: March 5, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Treatment

Phase I Arm A

Phase I Arm B

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 A
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

  • St Vincent's Hospital Sydney

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Peter MacCallum Cancer Center

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Parkville, Victoria 3052
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Parkville 2153770, Victoria 2145234 3052
    Australia

    Site Not Available

  • British Columbia Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Active - Recruiting

  • British Columbia Cancer Agency

    Vancouver 6173331, British Columbia 5909050 V5Z 4E6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 1X6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto 6167865, Ontario 6093943 M5G 1X6
    Canada

    Site Not Available

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Hadassah University Hospital - Ein Kerem

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Ramat Gan, 5262100
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan 293788, 5262100
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center PPDS

    Tel Aviv-Yafo, 6423906
    Israel

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • National Cancer Centre

    Singapore, 168583
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119074
    Singapore

    Active - Recruiting

  • National Cancer Centre

    Singapore 1880252, 168583
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore 1880252, 119074
    Singapore

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, 13620
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam 6876792, 13620
    South Korea

    Site Not Available

  • Asan Medical Center.

    Seoul, 005505
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722
    South Korea

    Active - Recruiting

  • Asan Medical Center.

    Seoul 1835848, 005505
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 3722
    South Korea

    Active - Recruiting

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

    Barcelona, 08035
    Spain

    Active - Recruiting

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

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

    Madrid 3117735, 28050
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - PPDS

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • Western General Hospital;Edinburgh Cancer Center

    Edinburgh, Midlothian EH4 2LF
    United Kingdom

    Active - Recruiting

  • Western General Hospital;Edinburgh Cancer Center

    Edinburgh 2650225, Midlothian EH4 2LF
    United Kingdom

    Site Not Available

  • NIHR UCLH Clinical Research Facility

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • NIHR UCLH Clinical Research Facility

    London 2643743, W1T 7HA
    United Kingdom

    Site Not Available

  • The Christie

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • The Christie

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital - Surrey

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital - Surrey

    Sutton 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • UC San Diego Moores Cancer Center

    La Jolla, California 92093-1503
    United States

    Active - Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla 5363943, California 5332921 92093-1503
    United States

    Site Not Available

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Florida Cancer Specialist-Lake Mary

    Lake Mary, Florida 32746
    United States

    Active - Recruiting

  • Florida Cancer Specialist-Lake Mary

    Lake Mary 4161373, Florida 4155751 32746
    United States

    Site Not Available

  • University of Illinois

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University of Illinois

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • START - Midwest - EDOS

    Grand Rapids, Michigan 49546-7062
    United States

    Active - Recruiting

  • START - Midwest - EDOS

    Grand Rapids 4994358, Michigan 5001836 49546-7062
    United States

    Site Not Available

  • Montefiore Einstein Cancer Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Montefiore Einstein Cancer Center

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Montefiore Einstein Cancer Center

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Mary Crowley Medical Research Center

    Dallas, Pennsylvania 75230-2571
    United States

    Active - Recruiting

  • Abramson Cancer Center;Univ of Pennsylvania

    Philadelphia, Pennsylvania 19104-5127
    United States

    Active - Recruiting

  • Mary Crowley Medical Research Center

    Dallas 5186266, Pennsylvania 6254927 75230-2571
    United States

    Site Not Available

  • Abramson Cancer Center;Univ of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19104-5127
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

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