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

Phase Ib/II, Open Label, Controlled 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 After First-line Treatment Failure

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study is also going to evaluate the combination therapy or monotherapy: 1. overall survival time ((OS)), disease control rate (DCR) and duration of remission (DOR) in patients with metastatic melanoma. 2. safety 3. the relationship between the expression of PD-L1 in tumor tissue and clinical effect； 4. the changes of immune microenvironment (CD8+ expression) in tumor tissue before and after Pexa-vec treatment.

Conditions

• Local Progression or Metastatic Melanoma With Failed First-line Treatment

Interventions

Type	Name	Description
BIOLOGICAL	Pexa-Vec combined with ZKAB001	1. Intratumoral injection of low dose Pexa-Vec (3×10\^8pfu) combined with intravenous of ZKAB001 (5mg/kg), every 2 weeks as one cycle. 2. Intratumoral injection of high dose Pexa-Vec (1×10\^9pfu) combined with intravenous of ZKAB001 (5mg/kg), every 2 weeks as one cycle.
BIOLOGICAL	ZKAB001 monotherapy	ZKAB001 monotherapy

Timeline

• Start date: 2021-08-26
• Primary completion: 2022-05-31
• Completion: 2023-05-31
• First posted: 2021-04-19
• Last updated: 2022-03-31

Locations

1 site across 1 country: China