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

Detailed 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

Interventions

Drug
Phase I Arm A
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Drug
Phase I Arm B
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Locations (43)

UC San Diego Moores Cancer Center
La Jolla, California
Sarah Cannon Research Institute at HealthONE
Denver, Colorado
Yale Cancer Center
New Haven, Connecticut
Florida Cancer Specialist-Lake Mary
Lake Mary, Florida
University of Illinois
Chicago, Illinois
Dana Farber Cancer Institute
Boston, Massachusetts