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NCT06619587PHASE1Recruiting

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

Genentech, Inc.

Start Date

11/14/2024

Completion Date

5/31/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Phase I Arm A

DRUG

Phase I Arm B

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Conditions

Solid Tumor

Locations

UC San Diego Moores Cancer Center

La Jolla, California 92093-1503

United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado 80218

United States

Yale Cancer Center

New Haven, Connecticut 06510

United States

Florida Cancer Specialist-Lake Mary

Lake Mary, Florida 32746

United States

University of Illinois

Chicago, Illinois 60612

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

START - Midwest - EDOS

Grand Rapids, Michigan 49546-7062

United States

Montefiore Einstein Cancer Center

The Bronx, New York 10461

United States

Mary Crowley Medical Research Center

Dallas, Pennsylvania 75230-2571

United States

Abramson Cancer Center;Univ of Pennsylvania

Philadelphia, Pennsylvania 19104-5127

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

O'Quinn Medical Tower at McNair Campus

Houston, Texas 77054

United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales 2010

Australia

Slade Health Inward goods

Mount Kuring-Gai, New South Wales 2080

Australia

Peter Maccallum Cancer Centre

Parkville, Victoria 3052

Australia

British Columbia Cancer Agency

Vancouver, British Columbia V5Z 4E6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 1X6

Canada

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec H3T 1E2

Canada

Gustave Roussy

Villejuif, Val-de-Marne 94805

France

Institut Bergonie

Bordeaux, 33076

France

Centre Georges Francois Leclerc

Dijon, 21000

France

Rambam Health Care Campus

Haifa, 3109601

Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001

Israel

The Chaim Sheba Medical Center

Ramat Gan, 5262100

Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, 6423906

Israel

National University Hospital

Singapore, 119074

Singapore

National Cancer Centre

Singapore, 168583

Singapore

Seoul National University Bundang Hospital

Seongnam, 13620

South Korea

Asan Medical Center.

Seoul, 005505

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 3722

South Korea

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, 08035

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, 28050

Spain

Hospital Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, 41013

Spain

Hospital Clinico Universitario de Valencia

Valencia, 46010

Spain

Western General Hospital;Edinburgh Cancer Center

Edinburgh, Midlothian EH4 2LF

United Kingdom

NIHR UCLH Clinical Research Facility

London, W1T 7HA

United Kingdom

The Christie

Manchester, M20 4BX

United Kingdom

Royal Marsden Hospital - Surrey

Sutton, SM2 5PT

United Kingdom