Advanced malignancies
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGPEMBROLIZUMAB
DRUGPM54
Sponsors
Pharma Mar S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed