NCT02740270

Phase I/Ib Study of GWN323 Alone and in Combination With PDR001 in Patients With Advanced Malignancies and Lymphomas

A Phase I/Ib Open-label, Multi-center, Dose Escalation Study of GWN323 (Anti-GITR) as a Single Agent and in Combination With PDR001 (Anti-PD-1) in Patients With Advanced Solid Tumors and Lymphomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to explore the clinical utility of two investigational antibodies in patients with advanced cancer or lymphomas. This is a multi-center, open-label Phase I/Ib study. The study consists of two dose escalation parts and two dose expansion parts testing GWN323 as a single agent or GWN323 in combination with PDR001. The dose escalation parts will estimate the MTD and/or RDE and test different dosing schedules. The dose expansion parts of the study will use the MTD/RDE determined in the dose escalation part to assess the activity, safety and tolerability of the investigational products in patients with specific types of cancer and lymphomas. Approximately 264 adult patients with advanced solid tumors or lymphomas will be enrolled.

Conditions

• Solid Tumors
• Lymphomas

Interventions

Type	Name	Description
DRUG	GWN323
DRUG	PDR001

Timeline

• Start date: 2016-07-22
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2016-04-15
• Last updated: 2021-02-21

Locations

9 sites across 6 countries: United States, Canada, Israel, Japan, Singapore, Spain

Regulatory

• FDA-regulated drug study