RecruitingPhase 1NCT07260591

VSV-02 Compassionate Use in Advanced Solid Tumors

A Single-Arm, Open-Label, Compassionate Use Study of VSV-02 Administered Intravenously and Intratumorally in Patients With Advanced Solid Tumors


Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Enrollment

6 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a compassionate use study offering VSV-02 — an experimental oncolytic virus (a virus engineered to attack cancer cells) — to patients with advanced solid tumors who have run out of standard treatment options. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumor (such as melanoma, head and neck cancer, cervical cancer, lung, breast, colorectal, liver, gastric, or other cancers) - Your cancer has progressed after at least two prior lines of treatment, or no standard treatment is available or appropriate for you - You are in adequate physical condition to receive treatment **You may NOT be eligible if...** - You have serious uncontrolled infections - You have significant heart, liver, or kidney failure - You have active brain metastases that are untreated - You cannot meet other safety requirements for the experimental treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVSV-02 Injection

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.


Locations(1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

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NCT07260591


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