A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies.

Official Title

A Phase I/Ib, Open-label, Multi-centre, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies.

Summary:

The purpose of this study is to assess the safety, tolerability, and preliminary anti-tumour activity of experimental medication NZV930 alone and when combined with PDR001 and/or NIR178, in patients with advanced cancers

Trial Description

Primary Outcome:

• Number of participants with adverse events as a measure of safety and tolerability of the NZV930 in combination with PDR001 and/or NIR178

• Overall response rate (ORR)
• Clinical Benefit Rate (CBR)
• Progression Free Survival (PFS)
• Serum concentration vs. time profiles of NZV930 (free drug) and PDR001.
• Plasma concentration vs. time profiles for NIR178 and derived PK parameters
• To assess the immunogenicity of NZV930 and PDR001
• Characterize changes in the immune infiltrate in tumours

View this trial on ClinicalTrials.gov