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

Purpose

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.

Condition

Solid Tumor

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts 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

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Phase I Arm A	Dose escalation and expansion arm	Drug: Phase I Arm A Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Experimental Phase I Arm B	Dose escalation and expansion arm	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

Recruiting Locations

UC San Diego Moores Cancer Center
La Jolla 5363943, California 5332921 92093-1503

Sarah Cannon Research Institute at HealthONE
Denver 5419384, Colorado 5417618 80218

Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06510

Florida Cancer Specialist-Lake Mary
Lake Mary 4161373, Florida 4155751 32746

University of Illinois
Chicago 4887398, Illinois 4896861 60612

Dana Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215

START - Midwest - EDOS
Grand Rapids 4994358, Michigan 5001836 49546-7062

Montefiore Einstein Cancer Center
The Bronx 5110266, New York 5128638 10461

Mary Crowley Medical Research Center
Dallas 5186266, Pennsylvania 6254927 75230-2571

Abramson Cancer Center;Univ of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104-5127

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

More Details

NCT ID: NCT06619587
Status: Recruiting
Sponsor: Genentech, Inc.

Study Contact

Reference Study ID Number: GO45416 https://forpatients.roche.com/
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.