A Phase I/Ib, Open-Label, Multi-Center Study of NZV930 as a Single Agent and in Combination with PDR001 and/or NIR178 in Patients with Advanced Malignancies
This is a First In Human study of NZV930 to characterize the safety, tolerability, PK, PD and antitumor activity of NZV930 as a single agent and in combination with PDR001 and/or NIR178 in adult patients with advanced malignancies.
Primary Objectives To characterize the safety and tolerability of NZV930 as a single agent and in combination with PDR001 and/or NIR178 in patients with advanced malignancies. To determine the recommended dose (RD) for expansion for single agent NZV930 and in combinations with PDR001 and/or NIR178 Secondary Objectives To assess the preliminary anti-tumor activity of NZV930 as a single agent and in combination with PDR001 and/or NIR178 To characterize the pharmacokinetics (PK) of NZV930 as a single agent and in combination with PDR001 and/or NIR178 To assess the immunogenicity of NZV930 and PDR001 ¿h To characterize changes in the immune infiltrate in tumors following the administration of NZV930 as a single agent and in combination with PDR001 and/or NIR178.
NIR178 (); NZV930 (); PDR001 (Spartalizumab)
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