Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Percutaneously Accessible Advanced Solid Tumors

Summary

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Description

This study aims to assess the safety and efficacy of LTX-315 in combination with the immune checkpoint inhibitor (ICI) pembrolizumab in patients with superficial advanced solid tumors. LTX-315 has been administered with pembrolizumab in a previous Phase 1/2 study (Study C12-315-03), and there were c...

This study aims to assess the safety and efficacy of LTX-315 in combination with the immune checkpoint inhibitor (ICI) pembrolizumab in patients with superficial advanced solid tumors. LTX-315 has been administered with pembrolizumab in a previous Phase 1/2 study (Study C12-315-03), and there were clear indications that LTX-315 + pembrolizumab was a clinically active combination. Furthermore, the addition of LTX-315 to pembrolizumab dosing did not appear to increase the overall incidence or severity profile of toxicities. The present study will document the preliminary efficacy, clinical safety, and tolerability of LTX-315 in combination with pembrolizumab, in a dose and regimen that is considered to be safe, in 2 cohorts of patients: Cohort 1 will consist of patients with selected tumors that have an FDA-approved ICI treatment and have progressed after prior anti-programmed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) therapy, alone or in combination with systemic therapy. Cohort 2 will consist of patients with tumors that do not have any FDA-approved ICI treatment, and may or may not have received prior anti-PD-1 or anti-PD-L1 therapy. The rationale for including this cohort is to test the ability of intratumoral injection of LTX-315 to convert an immunologically "cold" tumor to "hot" by causing cytolysis within the tumor.

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