RecruitingInterventionalPhase 1

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

NCT ID: NCT06619587Sponsor: Genentech, Inc.Last updated: 2026-06-01

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.

Arms & 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

Outcome measures

Primary

Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
Time frame: 4 Years
Percentage of Participants with Dose Limiting Toxicity
Time frame: 4 Years

Secondary

Plasma Concentrations of GDC-7035 at Specified Timepoints
Time frame: 4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints
Time frame: 4 Years
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Time frame: 4 Years
Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Time frame: 4 Years
Objective Response Rate Among Participants
Time frame: 4 Years
Duration of Response Among Participants
Time frame: 4 Years
Median Progression Free Survival Time Among Participants
Time frame: 4 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (12)

UC San Diego Moores Cancer Center

La Jolla, California, 92093-1503

Recruiting

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218

Recruiting

Yale Cancer Center

New Haven, Connecticut, 06510

Recruiting

Florida Cancer Specialist-Lake Mary

Lake Mary, Florida, 32746

Completed

University of Illinois

Chicago, Illinois, 60612

Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

START - Midwest - EDOS

Grand Rapids, Michigan, 49546-7062

Recruiting

Montefiore Einstein Cancer Center

The Bronx, New York, 10461

Recruiting

Mary Crowley Medical Research Center

Dallas, Pennsylvania, 75230-2571

Recruiting

Abramson Cancer Center;Univ of Pennsylvania

Philadelphia, Pennsylvania, 19104-5127

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

O'Quinn Medical Tower at McNair Campus

Houston, Texas, 77054

Recruiting