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

Official Title

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

Summary:

The purpose of this trial is to explore the clinical utility of several therapies in patients with advanced cancer.

This is a multi-centre, open-label Phase I/Ib study. The study consists of a dose escalation part, a dose expansion part testing KAZ954 as a single agent or KAZ954 in combination with PDR001, NZV930 and NIR178. The dose escalation parts will estimate the MTD and/or RD 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.

Approximately 135 adult patients with advanced solid tumours will be enrolled.

Trial Description

Primary Outcome:

• Incidence of Dose Limiting Toxicities (DLTs)
• Incidence of adverse events and serious adverse events
• Number of participants with dose interruptions and dose reductions
• Dose intensity of study treatment

• Overall Response Rate (ORR)
• Disease Control Rate (DCR)
• Progression Free Survival (PFS)
• Serum concentration profiles of KAZ954 as a single agent Cmax
• Serum concentration of KAZ954 in combination with PDR001 and derived PK parameters Cmax
• Serum concentration of KAZ954 in combination with NZV930 and derived PK parameters Cmax
• Serum/Plasma concentration of KAZ954 in combination with NIR178 Cmax
• Presence and titer of anti-KAZ954 antibodies
• Presence and titer of anti-PDR001 antibodies
• Presence and titer of anti-NZV930 antibodies
• Serum concentration profiles of KAZ954 as a single agent AUC
• Serum concentration profiles of KAZ954 in combination with PDR001 and derived PK parameters AUC
• Serum concentration profiles of KAZ954 incombination with NZV930 and derived PK parameters AUC
• Serum/Plasma concentration profiles of KAZ954 in combination with NIR178 and derived PK parameters AUC
• Assess the correlation between PD-L1 expression level in tumour using a validated assay and response to KAZ954 and in combo with PDR001, NIR178 or NZV930

View this trial on ClinicalTrials.gov