Recruiting
Phase 1

GDC-7035

Sponsor:

Genentech, Inc.

Code:

NCT06619587

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Phase I Arm A

Phase I Arm B

Study Details

Brief 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.

Conditions

Solid Tumor

Study ID

NCT06619587

Start date

Nov 14, 2024

Status verified date

Aug, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

410 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase I Arm A

Dose escalation and expansion arm

experimental: Phase I Arm B

Dose escalation and expansion arm

Interventions

Phase I Arm A

Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035

Phase I Arm B

Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S.)global-roche-genentech-trials@gene.com

Locations

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093-1503

Sarah Cannon Research Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06510

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

START - Midwest - EDOS

Recruiting

Grand Rapids, Michigan, United States, 49546-7062

Montefiore Einstein Cancer Center

Recruiting

The Bronx, New York, United States, 10461

Mary Crowley Medical Research Center

Recruiting

Dallas, Pennsylvania, United States, 75230-2571

Abramson Cancer Center;Univ of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104-5127

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

O'Quinn Medical Tower at McNair Campus

Recruiting

Houston, Texas, United States, 77054

British Columbia Cancer Agency

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1X6

Sir Mortimer B Davis Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Genentech, Inc.

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Genentech, Inc. on 2026-08-25.