NCT04237649

KAZ954 Alone and With PDR001, NZV930 and NIR178 in Advanced Solid Tumors

A Phase I/Ib, Open-label, Multi-center, Study of KAZ954 as a Single Agent and in Combination With Spartalizumab, NZV930 and NIR178 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the trial was to characterize the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose (RD) for expansion of single agent KAZ954 and KAZ954 in combination with PDR001, NIR178 and NZV930.

Detailed description

The purpose of this trial was to explore the clinical utility of several therapies in patients with advanced cancer. This is a multi-center, open-label Phase I/Ib study. The study consisted of a dose escalation part and a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178. The dose escalation part estimated the MTD and/or RD and tested different dosing schedules. The dose escalation arm KAZ954 + NZV930 was not opened. The dose expansion part of the study was planned to 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. The dose expansion part of the study was not started.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	KAZ954	KAZ954 will be administered in every arm.
DRUG	PDR001	KAZ954 + PDR001
DRUG	NIR178	KAZ954 + NIR178
DRUG	NZV930	KAZ954 + NZV930

Timeline

• Start date: 2020-02-20
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2020-01-23
• Last updated: 2025-05-18

Locations

13 sites across 8 countries: United States, Canada, Hong Kong, Italy, Japan, Singapore, Spain, Taiwan

Regulatory

• FDA-regulated drug study