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

This is a first‐in‐human (FIH), Phase 1/2, open‐label, multicenter, dose escalation, anddose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity,and tumor response of the investigational drug KVA12123 alone and in combination withpembrolizumab in adults with relapsed or refractory advanced solid tumors. The study willbe conducted in 4 parts: Parts A and B will focus on dose escalation (single‐agent and incombination), and Parts C and D will focus on dose expansion (single‐agent and incombination).Parts A (single‐agent KVA12123) and B (KVA12123 + pembrolizumab) will comprise up to 10dose escalation cohorts (6 for Part A and 4 for Part B) and treat 1‐6 participants ineach cohort to characterize the safety, tolerability, pharmacodynamics (PD),pharmacokinetics (PK) and preliminary tumor responses of study interventions. Theobjective of Parts A and B will be to determine a recommended Phase 2 dose (RP2D) forParts C and D.Parts C (single‐agent KVA12123) and D (KVA12123 + pembrolizumab) will comprise up to 7disease‐specific dose expansion cohorts (2 for Part C and 5 for Part D), which willcommence at the RP2D to further characterize the safety, tolerability, PD, PK, andpreliminary tumor response of KVA12123 alone and in combination with pembrolizumab.