Intratumoral AST-008 Combined With Pembrolizumab in Patients With Advanced Solid Tumors

This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral AST-008 injections alone and in combination with intravenous pembrolizumab in patients with advanced solid tumors.

Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of AST-008 given with a fixed dose of pembrolizumab.

Phase 2 is an expansion cohort to further evaluate AST-008 given in combination with pembrolizumab in specific a population to provide a preliminary estimate of efficacy in patients who have previously received and not responded anti-PD-1 or anti-PD-L1 antibody therapy.

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