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

Recruiting now · Phase 1

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT06619587

Run by

Genentech, Inc.

People needed

410

Starts

2024-11-14

Expected to finish

2028-05-31

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Royal Marsden Hospital - Surrey — Sutton, United Kingdom (enrolling)
• Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• University of Illinois — Chicago, Illinois, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• START - Midwest - EDOS — Grand Rapids, Michigan, United States (enrolling)
• Montefiore Einstein Cancer Center — The Bronx, New York, United States (enrolling)
• Mary Crowley Medical Research Center — Dallas, Pennsylvania, United States (enrolling)
• Abramson Cancer Center;Univ of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• O'Quinn Medical Tower at McNair Campus — Houston, Texas, United States (enrolling)
• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (enrolling)
• Slade Health Inward goods — Mount Kuring-Gai, New South Wales, Australia (enrolling)
• Peter Maccallum Cancer Centre — Parkville, Victoria, Australia (enrolling)
• British Columbia Cancer Agency — Vancouver, British Columbia, Canada (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• Sir Mortimer B Davis Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• Gustave Roussy — Villejuif, Val-de-Marne, France (enrolling)
• Institut Bergonie — Bordeaux, France (enrolling)
• Centre Georges Francois Leclerc — Dijon, France (enrolling)
• Rambam Health Care Campus — Haifa, Israel (enrolling)
• Hadassah University Hospital - Ein Kerem — Jerusalem, Israel (enrolling)
• The Chaim Sheba Medical Center — Ramat Gan, Israel (enrolling)
• Tel Aviv Sourasky Medical Center PPDS — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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