NCT05954871

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

A Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Patients With Unresectable, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer, or With Cetuximab in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Colorectal Cancer
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GDC-1971	GDC-1971 capsules or tablets will be administered as specified in each treatment arm.
DRUG	Osimertinib	Osimertinib tablets will be administered as specified in each treatment arm.
DRUG	Cetuximab	Cetuximab, solution for infusion will be administered as specified in each treatment arm.

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-09-16
• Completion: 2025-09-16
• First posted: 2023-07-20
• Last updated: 2025-11-13

Locations

6 sites across 3 countries: United States, Australia, South Korea

Regulatory

• FDA-regulated drug study