Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tumo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Active brain metastases.
- Malabsorption or other condition that interferes with enteral absorption.
- Clinically significant cardiovascular dysfunction or liver disease.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 24 2026
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT04449874
Start Date
July 29 2020
End Date
September 24 2026
Last Update
October 16 2025
Active Locations (67)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
3
Chao Family Comprehensive Cancer Center UCI
Orange, California, United States, 92868
4
Yale Cancer Center
New Haven, Connecticut, United States, 06511