A Multicenter, Open-label, Phase 1/2 Safety Run-in and Expansion Study of PM54 in Combination With Immunotherapy Evaluating Safety and Efficacy in Adult Participants who were Previously Treated for Advanced Malignancies

Condition studied

Advanced malignancies

Investigational medicinal product(s)

Eligibility

Primary endpoint

Parts 1 and 2 Treatment-emergent adverse events (TEAEs), serious TEAEs, dose-limiting toxicities (DLTs), TEAEs leading to treatment discontinuation or dose modifications; these will be considered in the determination of the recommended dose (RD), Specific to Part 1 Only - DLTs during the DLT assessment period

Endpoint detail

Confirmed ORR per RECIST v1.1 (or mRECIST v1.1, where applicable) during the study, CBR in the first 12 weeks, Disease control rate, defined as the proportion of participants who achieve a best overall response of stable disease, PR, or CR as defined by RECIST v1.1 (or mRECIST v1.1, where applicable) during the study, Progression-free survival (PFS), Duration of response, Time to treatment failure, Overall survival, Plasma concentration of PM54 and pembrolizumab throughout the study