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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Genentech, Inc. • ClinicalTrials.gov ID: NCT06619587

Registry updated: 2026-09-23
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Description

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.

Interventions

  • Phase I Arm A (Drug)
    Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
  • Phase I Arm B (Drug)
    Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Eligibility criteria

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: * Malabsorption or other condition that would interfere with enteral absorption * Active brain metastases * Clinically significant cardiovascular dysfunction or liver disease

Conditions

Solid Tumor

Locations

  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
  • Yale Cancer Center — New Haven, Connecticut, United States
  • Florida Cancer Specialist-Lake Mary — Lake Mary, Florida, United States
  • University of Illinois — Chicago, Illinois, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • START - Midwest - EDOS — Grand Rapids, Michigan, United States
  • Montefiore Einstein Cancer Center — The Bronx, New York, United States
  • Mary Crowley Medical Research Center — Dallas, Pennsylvania, United States
  • Abramson Cancer Center;Univ of Pennsylvania — Philadelphia, Pennsylvania, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • O'Quinn Medical Tower at McNair Campus — Houston, Texas, United States
  • St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia
  • Slade Health Inward goods — Mount Kuring-Gai, New South Wales, Australia
  • Peter Maccallum Cancer Centre — Parkville, Victoria, Australia
  • British Columbia Cancer Agency — Vancouver, British Columbia, Canada
  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Sir Mortimer B Davis Jewish General Hospital — Montreal, Quebec, Canada
  • Gustave Roussy — Villejuif, Val-de-Marne, France
  • Institut Bergonie — Bordeaux, France
  • Centre Georges Francois Leclerc — Dijon, France
  • Rambam Health Care Campus — Haifa, Israel
  • Hadassah University Hospital - Ein Kerem — Jerusalem, Israel
  • The Chaim Sheba Medical Center — Ramat Gan, Israel
  • Tel Aviv Sourasky Medical Center PPDS — Tel Aviv, Israel
  • Centro Richerche Cliniche di Verona — Verona, Veneto, Italy
  • Universitair Medisch Centrum Groningen — Groningen, Netherlands
  • National University Hospital — Singapore, Singapore
  • National Cancer Centre — Singapore, Singapore
  • Seoul National University Bundang Hospital — Seongnam, South Korea
  • Asan Medical Center. — Seoul, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, South Korea
  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC — Madrid, Spain
  • Hospital Universitario Virgen de la Victoria — Málaga, Spain
  • Hospital Universitario Virgen del Rocio - PPDS — Seville, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Western General Hospital;Edinburgh Cancer Center — Edinburgh, Midlothian, United Kingdom
  • NIHR UCLH Clinical Research Facility — London, United Kingdom
  • The Christie — Manchester, United Kingdom
  • Royal Marsden Hospital - Surrey — Sutton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record