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A Phase 1 Dose Escalation With Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMV564 in Subjects with Advanced Solid Tumors
This Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of AMV564 alone and in combination with Pembrolizumab in patients with advanced solid tumors.
The primary objective of the dose-escalation stage of the study is: To characterize the safety profile and tolerability of AMV564, including cumulative toxicities -to determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of AMV564 in patients with locally advanced or metastatic solid tumors The primary objectives of the dose-expansion stage of the study are: -to further characterize the safety and tolerability of AMV564 at the MTD/RP2D -to evaluate preliminary efficacy of AMV564 at the MTD/RP2D The secondary objectives of this study are: -to evaluate the pharmacokinetic (PK) profile of AMV564 -to assess the pharmacodynamics, immune response, and preliminary disease response/clinical activity of AMV564 Exploratory Objectives: -to determine the relationship between AMV564 PK and drug effects, including efficacy and safety -to evaluate potential predictive biomarkers for response -to evaluate potential predictive biomarkers for resistance
AMV564 (); Pembrolizumab (Keytruda)