VSV-02 Compassionate Use in Advanced Solid Tumors

Sponsor
The First Affiliated Hospital of Xinxiang Medical College
Study ID
NCT07260591
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VSV-02 Injection — BIOLOGICAL
    VSV-02 Injection is an oncolytic virus vaccine based on an attenuated Vesicular Stomatitis Virus (VSV) that is engineered to encode a CD3/PD-L1 bispecific antibody. It is supplied as a sterile solution by Shanghai Rongrui Pharmaceutical Technology Co., Ltd., with a specification of 1 mL per vial and a viral titer of 3.0×10\^10 PFU/mL. The investigational product is administered via two routes: intratumoral (IT) injection followed by intravenous (IV) infusion on Day 1 (D1) of each 21-day treatment cycle. Patients may receive up to 6 cycles of treatment. In this dose-escalation study, participants are enrolled into predefined dose cohorts. The starting dose for the first cohort is 6×10\^10 PFU via intratumoral injection and 6×10\^11 PFU via intravenous infusion.

Study Details

This is a clinical study for patients with advanced solid tumors who have limited or no effective treatment options available. The study aims to evaluate a new investigational drug called VSV-02 Injection, which is developed by Shanghai Rongrui Pharmaceutical Technology Co., Ltd. The main purpose of this open-label, single-arm study is to assess the preliminary effectiveness and safety of VSV-02 when it is given through two routes: directly into a vein (intravenously) and by injection directly into the tumor (intratumorally). Patients will receive the treatment on the first day of each 3-week cycle, for up to 6 cycles. The study will follow a dose-escalation design to find a suitable dose. Treatment may be stopped if the disease progresses, if side effects become intolerable, or if the patient chooses to withdraw, among other reasons. Researchers will closely monitor patients to see if VSV-02 can help control the cancer and to record any side effects that may occur.

Key Dates

First listed
Dec 3, 2025
Start date
Sep 22, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: VSV-02 Dose Escalation Group
    Participants will receive VSV-02 via intravenous (IV) and intratumoral (IT) injection in a dose-escalation manner. The starting dose is 6×10\^10 PFU (IT) + 6×10\^11 PFU (IV). Dosing occurs on Day 1 of each 21-day cycle for up to 6 cycles.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From enrollment until the first occurrence of disease progression or the end of treatment, up to 24 months. ]

Central Contacts

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