Skip to main content

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

Trial Status: Active

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.

Inclusion Criteria

  • 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 as specified in the protocol.
  • Men who are not surgically sterile must agree to remain abstinent or use contraception, and agreement to refrain from donating sperm during the treatment period and after the final dose of study treatment as specified in the protocol.

Exclusion Criteria

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE

Connecticut

New Haven
Yale University
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Kathryn C Arbour
Phone: 646-449-1775

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Genentech Inc.

  • Primary ID GO42144
  • Secondary IDs NCI-2020-06315, 2020-000084-22
  • Clinicaltrials.gov ID NCT04449874