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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04237649.
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.
Lead OrganizationNovartis Pharmaceuticals Corporation