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

• Status: Recruiting
• Trial end date: 2023-08-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Atezolizumab; Bevacizumab; Cetuximab; Erlotinib Hydrochloride

Criteria

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 treatment 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.