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

ArmDescriptionAssigned 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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center