A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

Running, not enrolling · Phase 1

Conditions studied: Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumors

In brief

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.

Key facts

Study ID

NCT04449874

Run by

Genentech, Inc.

People needed

498

Starts

2020-07-29

Expected to finish

2027-12-31

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically documented advanced or metastatic solid tumor with KRAS G12C mutation.
• Women of childbearing potential must agree to remain abstinent or use contraception, and agree to refrain from donating eggs during the treatment period and after the final dose of study treatment as specified in the protocol.
• Men who are not surgically sterile must agree to remain abstinent or use a condom, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.

You may not qualify if…

• Active brain metastases.
• Malabsorption or other condition that interferes with enteral absorption.
• Clinically significant cardiovascular dysfunction or liver disease.

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States
• Chao Family Comprehensive Cancer Center UCI — Orange, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Abramson Cancer Center — Philadelphia, Pennsylvania, United States
• UPMC - Hillman Cancer Center — Pittsburgh, Pennsylvania, 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 Center — Melbourne, Victoria, Australia
• Alfred Health — Melbourne, Victoria, Australia
• Linear Clinical Research Limited — Nedlands, Western Australia, Australia
• UZ Antwerpen — Edegem, Belgium
• CHU de Liège — Liège, Belgium
• AZ St Maarten Campus Leopoldstr — Mechelen, Belgium
• Santa Casa de Misericordia de Belo Horizonte - PPDS — Belo Horizonte, Minas Gerais, Brazil
• Hospital Erasto Gaertner — Curitiba, Paraná, Brazil
• Hospital de Clinicas de Porto Alegre HCPA PPDS — Porto Alegre, Pará, Brazil
• Universidade de Caxias do Sul — Caxias do Sul, Rio Grande do Sul, Brazil
• Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) — Porto Alegre, Rio Grande do Sul, Brazil
• Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS — São José do Rio Preto, São Paulo, Brazil
• Instituto Nacional de Câncer — Rio de Janeiro, Brazil
• Ottawa Hospital — Ottawa, Ontario, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• City of Hope Comprehensive Cancer Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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