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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04237649
Study type Interventional
Source Novartis
Contact
Status Terminated
Phase Early Phase 1
Start date February 20, 2020
Completion date September 15, 2023

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