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VSV-02 Compassionate Use in Advanced Solid Tumors

NCT07260591 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

VSV-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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xinxiang Medical College

    lead OTHER

Principal Investigators

  • LiuZhong Yang, master · First Affiliated Hospital of Xinjiang Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07260591 on ClinicalTrials.gov