Clinical trialPhase 2Recruiting
Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Advanced Pancreatic Cancer
A Phase II Trial to Evaluate the Efficacy of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Pancreatic Tumors
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Recruiting
- Study type
- Interventional
- Start
- 29 May 2025
- Expected end
- 5 March 2029
- Enrollment
- 12 participants
- Sites
- 1
- Primary outcomes
- Anti-tumor activity of hV01: overall response rate (ORR).; Anti-tumor activity of hV01: disease control rate (DCR).; Anti-tumor activity of hV01: duration of response (DOR).
- Sponsor
- Industry
- Results posted
- No
- Last update
- 27 February 2026
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Brief summary public domain (ClinicalTrials.gov)
The main goal of this clinical trial is to preliminary evaluate the efficacy of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced pancreatic cancer.And the secondary purpose is to evaluate the safety of hV01.
Detailed description public domain (ClinicalTrials.gov)
This is a single-site, single-arm, open-label,exploratory phase Ⅱa study. Based on the safety results of the completed phase I clinical trial of hV01 , 8.0x10 \^ 8 PFU was selected as a dose level of the dosage for each administration in this clinical trial, hV01 will be administered with twice per cycle (on day 1 and day 15), efficacy evaluation will be conducted on day 28, and every 28 days as a treatment cycle,during which safety will be observed.