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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |