Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer

Sponsor
Zhejiang University
Study ID
NCT05162118
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This is a multicenter, open, single-arm design clinical trial coducted in HSV-seropositive subjects with advanced pancreatic cancer to determine the safety, tolerability and preliminary efficacy of VG161 combined with PD-1 inhibitor (Nivolumab Injection).

Key Dates

Start date
Mar 8, 2022
Status verified
Mar 2022
Primary completion
Mar 22, 2025
Completion
Dec 22, 2025

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    1. Intratumoral injection of VG161 - 1.5\*10\^8 on D1 + Nivolumab on D8, D22 2. Intratumoral injection of VG161 - 1.0\*10\^8 on D1, D2 + Nivolumab on D8, D22 3. Intratumoral injection of VG161 - 1.0\*10\^8 on D1, D2, D3 + Nivolumab on D8, D22

Primary Outcome Measure

MTD [ Time Frame: 1 month ]

Central Contacts