A Phase 1, Open-label, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UGN-301 (zalifrelimab) Administered Intravesically as Monotherapy and in Combination with Other Agents in Patients with Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
Objective
Primary: To determine the BED and MTD of UGN-301 as monotherapy and in combination with other agents in patients with recurrent NMIBC. To determine the RP2D of UGN-301 as monotherapy and in combination with other agents in patients with recurrent NMIBC.
Secondary: To evaluate the PK and immunogenicity of UGN-301 when administered as monotherapy and in combination with other agents. To evaluate the PK of UGN-201 in combination with UGN-301 (Arm B only).
