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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 410 (estimated) |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 49 sites (La Jolla, California and 48 other locations) |
| Status | Recruiting |
| Started | November 14, 2024 |
| Main results expected | May 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT06619587 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
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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
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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
- Study coordinator: Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below.
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
SumMET: Targeted radioligand therapy for c-MET–positive solid tumors
This first‑in‑human study tests the safety and potential effectiveness of a radioligand therapy called [225Ac]Ac-FL-261 in adults with advanced or metastatic solid tumors that overexpress c-MET.
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SHR-4595 Injection in Advanced Solid Tumors: Safety, Tolerability, and Dosing in Phase 1
This early-phase trial tests SHR-4595 injections to see if they are safe and tolerable for adults with advanced solid tumors who have exhausted standard treatments.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.