Phase 1 Dose-escalation Trial of OMTX705, an Anti-fibroblast Activation Protein Antibody-drug Conjugate, as Single Agent and in Combination With Anti-PD-1 in Patients With Advanced Solid Tumors
Oncomatryx Biopharma S.L.
Summary
Open-label, two parallel arm, multicenter, Phase 1 dose-escalation study to evaluate the safety and tolerability of OMTX705, both as monotherapy or in combination with pembrolizumab (Part 1) or tislelizumab (Part 2) in the treatment of patients with advanced or metastatic cancer in whom there is no available standard therapeutic option.
Description
The study consists of 2 parts: * Part 1: Phase 1 dose-escalation with two parallel staggered escalation cohorts: one cohort of patients treated with OMTX705 as monotherapy and one cohort of patients receiving escalating doses of OMTX705 in combination with standard pembrolizumab. The combination arm will start once OMTX705 monotherapy safety has been evaluated. * Part 2: Five cohorts expansions have been projected to confirm the safety of OMTX705 as monotherapy (SCHED1, SARC1 and BIOPSY) and in combination with tislelizumab (PDAC\_Low and PDAC\_High) will provide additional efficacy and safet…