RecruitingPhase 1NCT06619587

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

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

Sponsor

Genentech, Inc.

Enrollment

410 participants

Start Date

Nov 14, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Phase I Arm A and a drug called Phase I Arm B for people with solid tumor. The study is currently recruiting participants at 41 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhase I Arm A

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

DRUGPhase I Arm B

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

Locations(42)

UC San Diego Moores Cancer Center

La Jolla, California, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialist-Lake Mary

Lake Mary, Florida, United States

University of Illinois

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

START - Midwest - EDOS

Grand Rapids, Michigan, United States

Montefiore Einstein Cancer Center

The Bronx, New York, United States

Mary Crowley Medical Research Center

Dallas, Pennsylvania, United States

Abramson Cancer Center;Univ of Pennsylvania

Philadelphia, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

O'Quinn Medical Tower at McNair Campus

Houston, Texas, United States

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Slade Health Inward goods

Mount Kuring-Gai, New South Wales, Australia

Peter Maccallum Cancer Centre

Parkville, Victoria, Australia

British Columbia Cancer Agency

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

Gustave Roussy

Villejuif, Val-de-Marne, France

Institut Bergonie

Bordeaux, France

Centre Georges Francois Leclerc

Dijon, France

Rambam Health Care Campus

Haifa, Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Tel Aviv Sourasky Medical Center PPDS

Tel Aviv, Israel

Centro Richerche Cliniche di Verona

Verona, Veneto, Italy

National University Hospital

Singapore, Singapore

National Cancer Centre

Singapore, Singapore

Seoul National University Bundang Hospital

Seongnam, South Korea

Asan Medical Center.

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

START Madrid_Hospital Universitario HM Sanchinarro_CIOCC

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Western General Hospital;Edinburgh Cancer Center

Edinburgh, Midlothian, United Kingdom

NIHR UCLH Clinical Research Facility

London, United Kingdom

The Christie

Manchester, United Kingdom

Royal Marsden Hospital - Surrey

Sutton, United Kingdom

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NCT06619587

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