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

NCT ID: NCT06619587

Last Updated: 2026-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2028-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase I Arm A

Dose escalation and expansion arm

Group Type EXPERIMENTAL

Phase I Arm A

Intervention Type DRUG

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

Phase I Arm B

Dose escalation and expansion arm

Group Type EXPERIMENTAL

Phase I Arm B

Intervention Type DRUG

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

Interventions

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Phase I Arm A

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status RECRUITING

Florida Cancer Specialist-Lake Mary

Lake Mary, Florida, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

START - Midwest - EDOS

Grand Rapids, Michigan, United States

Site Status RECRUITING

Montefiore Einstein Cancer Center

The Bronx, New York, United States

Site Status RECRUITING

Mary Crowley Medical Research Center

Dallas, Pennsylvania, United States

Site Status RECRUITING

Abramson Cancer Center;Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Peter Maccallum Cancer Centre

Parkville, Victoria, Australia

Site Status RECRUITING

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Site Status RECRUITING

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Rambam Health Care Campus

Haifa, , Israel

Site Status RECRUITING

Hadassah University Hospital - Ein Kerem

Jerusalem, , Israel

Site Status RECRUITING

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, , Israel

Site Status RECRUITING

National University Hospital

Singapore, , Singapore

Site Status RECRUITING

National Cancer Centre

Singapore, , Singapore

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Asan Medical Center.

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio - PPDS

Seville, , Spain

Site Status RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Site Status RECRUITING

Western General Hospital;Edinburgh Cancer Center

Edinburgh, Midlothian, United Kingdom

Site Status RECRUITING

NIHR UCLH Clinical Research Facility

London, , United Kingdom

Site Status RECRUITING

The Christie

Manchester, , United Kingdom

Site Status RECRUITING

Royal Marsden Hospital - Surrey

Sutton, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Canada Israel Singapore South Korea Spain United Kingdom

Central Contacts

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Reference Study ID Number: GO45416 https://forpatients.roche.com/

Role: CONTACT

888-662-6728 (U.S.)

Other Identifiers

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GO45416

Identifier Type: -

Identifier Source: org_study_id

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