This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101, a tumor-selective anti-CTLA-4 antibody, as monotherapy and XTX101 and pembrolizumab combination therapy in patients with advanced solid tumors.~Part 1A will examine XTX101 monotherapy in an accelerated and standard 3+3 dose escalation design. Based on the results of Part 1A, patients with select advanced solid tumors will be enrolled in Part 1B, which will evaluate XTX101 monotherapy in relation to specific PD biomarkers.~Part 1C will examine XTX101 in combination with pembrolizumab in a standard 3+3 dose escalation design, examining up to 2 dose levels of XTX101 in combination with the labeled dose of pembrolizumab. After completion of Part 1C, the study will initiate Part 2, examining the RP2D of XTX101 and pembrolizumab combination therapy in patients with unresectable or metastatic melanoma.
This is a first-in-human, Phase 1/2, multicenter, open-label study designed to evaluate the safety and tolerability of XTX101 as monotherapy and XTX101 and pembrolizumab combination therapy in patients with advanced solid tumors.