Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Participants With Metastatic Colorectal Cancer
NCT05954871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-11-13
Summary
The main purpose of the study is to evaluate the safety of GDC-1971 in combination with either osimertinib or cetuximab. The study consists of a dose-finding stage followed by an expansion stage.
Conditions
Interventions
- DRUG
-
GDC-1971
GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
- DRUG
-
Osimertinib tablets will be administered as specified in each treatment arm.
- DRUG
-
Cetuximab, solution for infusion will be administered as specified in each treatment arm.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-08
- Primary Completion
- 2025-09-16
- Completion
- 2025-09-16
- FDA Drug
- Yes
Countries
- United States
- Australia
- South Korea
Study Locations
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