Evaluating GDC-7035 for advanced solid tumors with KRAS G12D mutation
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
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 |
| Enrollment | 410 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 38 sites (La Jolla, California and 37 other locations) |
| Trial ID | NCT06619587 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with histologically confirmed advanced or metastatic solid tumors that possess the KRAS G12D mutation.
Not a fit: Patients with active brain metastases, significant cardiovascular dysfunction, or liver disease may not benefit from this study.
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 performed: While this approach is novel in targeting the KRAS G12D mutation specifically, similar studies targeting KRAS mutations have shown promise in the past.
Eligibility criteria
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 this trial is running
La Jolla, California and 37 other locations
- 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)
- Florida Cancer Specialist-Lake Mary — Lake Mary, Florida, United States (Completed)
- 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)
- 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)
- 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)
- Institut Bergonie — Bordeaux, France (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)
- 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)
Study contacts
- Study coordinator: Reference Study ID Number: GO45416 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S.)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.