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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 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Lee's Pharmaceutical Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04849260 on ClinicalTrials.gov