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A Study of B-701 in Combination With Pembrolizumab in Treatment of Locally Advanced or Metastatic Urothelial Cell Carcinoma (FIERCE-22)

Phase 1b Primary Objective: To evaluate the initial safety and to identify the recommended Phase 2 dose (RP2D) of B-701 and pembrolizumab Phase 2 Primary Objectives: 1. To evaluate the safety and tolerability of B-701 plus pembrolizumab in subjects with UCC. 2. To evaluate efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Secondary Objectives: 1. To evaluate the change in expression of markers associated with tumor subtype, immune cell infiltrate, and immune response when B-701 is administered alone during the 14-day lead-in period. 2. To evaluate the efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by duration of objective response (DOR), progression free survival (PFS), and disease control rate (DCR), and overall survival (OS) by RECIST 1.1 3. To describe the impact of FGFR3 status at enrollment [wildtype (WT), mutation and/or fusion (MF)] on the safety and efficacy after one cycle of B-701 alone, followed by B-701 in combination with pembrolizumab in subjects with advanced UCC 4. To evaluate the change in patient reported outcome (PRO) quality of life measurements over time by the European Organization for Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30) Exploratory Objectives: 1. To evaluate the pharmacokinetics (PK) of B-701 in subjects with UCC 2. To assess the immunogenicity of B-701 in subjects with UCC 3. To determine if other molecular markers predict treatment response

Phase 1b Primary Objective: To evaluate the initial safety and to identify the recommended Phase 2 dose (RP2D) of B-701 and pembrolizumab Phase 2 Primary Objectives: 1. To evaluate the safety and tolerability of B-701 plus pembrolizumab in subjects with UCC. 2. To evaluate efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Secondary Objectives: 1. To evaluate the change in expression of markers associated with tumor subtype, immune cell infiltrate, and immune response when B-701 is administered alone during the 14-day lead-in period. 2. To evaluate the efficacy of B-701 in combination with pembrolizumab in the treatment of subjects with UCC as measured by duration of objective response (DOR), progression free survival (PFS), and disease control rate (DCR), and overall survival (OS) by RECIST 1.1 3. To describe the impact of FGFR3 status at enrollment [wildtype (WT), mutation and/or fusion (MF)] on the safety and efficacy after one cycle of B-701 alone, followed by B-701 in combination with pembrolizumab in subjects with advanced UCC 4. To evaluate the change in patient reported outcome (PRO) quality of life measurements over time by the European Organization for Research and Treatment Quality of Life Questionnaire (EORTC QLQ-C30) Exploratory Objectives: 1. To evaluate the pharmacokinetics (PK) of B-701 in subjects with UCC 2. To assess the immunogenicity of B-701 in subjects with UCC 3. To determine if other molecular markers predict treatment response