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

May 28, 2026 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

410

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital Sydney
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • Peter MacCallum Cancer Centre
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • British Columbia Cancer Agency
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Recruiting
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Sir Mortimer B Davis Jewish General Hospital
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • Institut Bergonié
      • Dijon, France, 21000
        • Recruiting
        • Centre Georges François Leclerc
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Gustave Roussy
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah University Hospital - Ein Kerem
      • Ramat Gan, Israel, 5262100
        • Recruiting
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center PPDS
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
      • Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre
  • South Korea
      • Seongnam, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, South Korea, 3722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 005505
        • Recruiting
        • Asan Medical Center.
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28050
        • Recruiting
        • START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
      • Seville, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
  • United Kingdom
      • London, United Kingdom, W1T 7HA
        • Recruiting
        • NIHR UCLH Clinical Research Facility
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital - Surrey
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH4 2LF
        • Recruiting
        • Western General Hospital;Edinburgh Cancer Center
  • United States
    • California
      • La Jolla, California, United States, 92093-1503
        • Recruiting
        • UC San Diego Moores Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at HealthONE
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale Cancer Center
    • Florida
      • Lake Mary, Florida, United States, 32746
        • Completed
        • Florida Cancer Specialist-Lake Mary
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49546-7062
        • Recruiting
        • START - Midwest - EDOS
    • New York
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Einstein Cancer Center
    • Pennsylvania
      • Dallas, Pennsylvania, United States, 75230-2571
        • Recruiting
        • Mary Crowley Medical Research Center
      • Philadelphia, Pennsylvania, United States, 19104-5127
        • Recruiting
        • Abramson Cancer Center;Univ of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • O'Quinn Medical Tower at McNair Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Concentrations of GDC-7035 at Specified Timepoints
Time Frame: 4 Years
4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints
Time Frame: 4 Years
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
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
4 Years
Objective Response Rate Among Participants
Time Frame: 4 Years
4 Years
Duration of Response Among Participants
Time Frame: 4 Years
4 Years
Median Progression Free Survival Time Among Participants
Time Frame: 4 Years
4 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO45416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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