A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

This was a first-in-human (FIH), Phase 1/2, open-label, multicenter, dose escalation, and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, and tumor response of the investigational drug KVA12123, subsequently designated TBS-2025, alone and in combination with pembrolizumab in adults with relapsed or refractory advanced solid tumors. The study was planned to conduct in 4 planned parts: Parts A and B focus on dose escalation (single-agent and in combination), and Parts C and D focus on dose expansion (single-agent and in combination). Parts A (single-agent KVA12123) and B (KVA12123 + pembrolizumab) allowed up to 10 dose escalation cohorts: 6 in Part A and 4 in Part B, with 1 to 6 participants per cohorts. These parts were intended to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary tumor response, and to inform the selection of recommended phase 2 doses. Parts C (single-agent KVA12123) and D (KVA12123 + pembrolizumab) were planned but not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern.