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
Genentech, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugPhase I Arm A
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
- DrugPhase I Arm B
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
Locations (38)
- UC San Diego Moores Cancer CenterLa Jolla, California
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Florida Cancer Specialist-Lake MaryLake Mary, Florida
- University of IllinoisChicago, Illinois
- Dana Farber Cancer InstituteBoston, Massachusetts