drugset / Trial / NCT04849260

Phase Ib/II Clinical Study of Pexa-Vec (Vaccinia GM CSF / Thymidine Kinase-Deactivated Virus) Combined With Recombinant Whole Human Anti-PD-L1 Monoclonal Antibody (ZKAB001) in Metastatic Melanoma

NCT04849260

Phase 1/2 Unknown 54 enrolled Lee's Pharmaceutical Limited
RandomizedParallel-groupOpen-labelTreatment

Summary

The study will be divided into two stages: phase Ib and phase II. The safety and phase II recommended dose (RP2D) of Pexa-Vec combined with ZKAB001 in patients with local progression of failed first-line treatment or metastatic melanoma will be evaluated in phase Ib. Objective response rate (ORR) and progression-free survival (PFS) of ZKAB001 combined with RP2D's Pexa-Vec or ZKAB001 monotherapy in patients with local progression or metastatic melanoma will be evaluated in phase II.

Timeline

Start
2021-08-26
Primary completion
2022-05-31
Completion
2023-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pexastimogene Devacirepvec Other / unclassified 3e+08 unknown Other
Subject Pexastimogene Devacirepvec Other / unclassified 1e+09 unknown Other
Subject Socazolimab Monoclonal antibody 5 mg/kg Intravenous

Indications