Clinical trial Recruiting at 48 sites Phase 1 Interventional Ages 18 and up

Evaluating GDC-7035 for advanced solid tumors with KRAS G12D mutation

Official title: 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

Run by Genentech, Inc. · NCT06619587 · Data updated 2026-11-12

This study is testing a new drug called GDC-7035 to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation, either on its own or with other cancer treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment410 (estimated)
SponsorGenentech, Inc.
Industry-sponsored
Locations49 sites (La Jolla, California and 48 other locations)
StatusRecruiting
StartedNovember 14, 2024
Main results expectedMay 31, 2028
Study endsMay 31, 2028
Registry record updatedOctober 23, 2026
Trial IDNCT06619587 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals with histologically confirmed advanced or metastatic solid tumors that possess the KRAS G12D mutation.

Probably not a fit

Patients with active brain metastases, significant cardiovascular dysfunction, or liver disease may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I study aims to assess the safety, pharmacokinetics, and preliminary activity of GDC-7035, both as a standalone treatment and in combination with other anti-cancer therapies. It focuses on patients with advanced or metastatic solid tumors specifically harboring the KRAS G12D mutation. The study employs a multicenter, open-label, dose-escalation design to gather data on the drug's effects and tolerability in this patient population.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have the KRAS G12D mutation.

How similar studies have gone: While this approach is novel in targeting the KRAS G12D mutation specifically, similar studies targeting KRAS mutations have shown promise in the past.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • UC San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • Sarah Cannon Research Institute at HealthONE
    Denver, Colorado, United States
    Recruiting
  • Yale Cancer Center
    New Haven, Connecticut, United States
    Recruiting
  • University of Illinois
    Chicago, Illinois, United States
    Recruiting
  • Dana Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • START - Midwest - EDOS
    Grand Rapids, Michigan, United States
    Recruiting
Show 43 more locations
  • Montefiore Einstein Cancer Center
    The Bronx, New York, United States
    Recruiting
  • Mary Crowley Medical Research Center
    Dallas, Pennsylvania, United States
    Recruiting
  • Abramson Cancer Center;Univ of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee, United States
    Recruiting
  • O'Quinn Medical Tower at McNair Campus
    Houston, Texas, United States
    Recruiting
  • St Vincent's Hospital Sydney
    Darlinghurst, New South Wales, Australia
    Recruiting
  • Slade Health Inward goods
    Mount Kuring-Gai, New South Wales, Australia
    Recruiting
  • Peter Maccallum Cancer Centre
    Parkville, Victoria, Australia
    Recruiting
  • British Columbia Cancer Agency
    Vancouver, British Columbia, Canada
    Recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting
  • Sir Mortimer B Davis Jewish General Hospital
    Montreal, Quebec, Canada
    Recruiting
  • Gustave Roussy
    Villejuif, Val-de-Marne, France
    Recruiting
  • Institut Bergonie
    Bordeaux, France
    Recruiting
  • Centre Georges Francois Leclerc
    Dijon, France
    Recruiting
  • Universitätsklinikum Ulm
    Ulm, Baden-Wurttemberg, Germany
    Recruiting
  • Universitätsklinikum Düsseldorf
    Düsseldorf, North Rhine, Germany
    Recruiting
  • Universitätsmedizin Mannheim
    Mannheim, Germany
    Recruiting
  • Rambam Health Care Campus
    Haifa, Israel
    Recruiting
  • Hadassah University Hospital - Ein Kerem
    Jerusalem, Israel
    Recruiting
  • The Chaim Sheba Medical Center
    Ramat Gan, Israel
    Recruiting
  • Tel Aviv Sourasky Medical Center PPDS
    Tel Aviv, Israel
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Rome, Lazio, Italy
    Recruiting
  • IRCCS Istituto Clinico Humanitas
    Rozzano, Lombardy, Italy
    Recruiting
  • Centro Richerche Cliniche di Verona
    Verona, Veneto, Italy
    Recruiting
  • Universitair Medisch Centrum Groningen
    Groningen, Netherlands
    Recruiting
  • Universitair Medisch Centrum Utrecht
    Utrecht, Netherlands
    Recruiting
  • National University Hospital
    Singapore, Singapore
    Recruiting
  • National Cancer Centre
    Singapore, Singapore
    Recruiting
  • Seoul National University Bundang Hospital
    Seongnam, South Korea
    Recruiting
  • Asan Medical Center.
    Seoul, South Korea
    Recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting
  • Severance Hospital, Yonsei University Health System
    Seoul, South Korea
    Recruiting
  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
    Barcelona, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Spain
    Recruiting
  • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
    Madrid, Spain
    Recruiting
  • Hospital Universitario Virgen de la Victoria
    Málaga, Spain
    Recruiting
  • Hospital Universitario Virgen del Rocio - PPDS
    Seville, Spain
    Recruiting
  • Hospital Clinico Universitario de Valencia
    Valencia, Spain
    Recruiting
  • Western General Hospital;Edinburgh Cancer Center
    Edinburgh, Midlothian, United Kingdom
    Recruiting
  • NIHR UCLH Clinical Research Facility
    London, United Kingdom
    Recruiting
  • The Christie
    Manchester, United Kingdom
    Recruiting
  • Royal Marsden Hospital - Surrey
    Sutton, United Kingdom
    Recruiting
  • Florida Cancer Specialist-Lake Mary
    Lake Mary, Florida, United States
    Terminated

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.