VSV-02 Compassionate Use in Advanced Solid Tumors

NCT07260591 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VSV-02A01tqyy
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Advanced Solid Tumor; Melanoma; Breast Cancer; Lung Cancer; Cancer Treatment; Immunotherapy

Outcome Measures

Primary Outcomes (5)

• Objective Response Rate (ORR)

  ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as assessed by the investigator.

  From enrollment until the first occurrence of disease progression or the end of treatment, up to 24 months.

• Disease Control Rate (DCR)

  DCR is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) (lasting for at least 6 weeks) per RECIST 1.1.

  From enrollment until the first occurrence of disease progression or the end of treatment, up to 24 months.

• Duration of Response (DoR)

  DoR is defined as the time from the first documentation of CR or PR to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first, as per RECIST 1.1.

  From the first objective response (CR or PR) until disease progression or death from any cause, assessed up to 36 months.

• Progression-Free Survival (PFS)

  PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first.

  From enrollment until the first occurrence of disease progression or death from any cause, assessed up to 36 months.

• verall Survival (OS)

  OS is defined as the time from enrollment to death due to any cause.

  From enrollment until death from any cause, assessed up to 60 months.

Secondary Outcomes (1)

• Incidence of Adverse Events (AEs)

  From first dose of study drug until 30 days after the last dose, up to 7 months.

Study Arms (1)

VSV-02 Dose Escalation Group

EXPERIMENTAL

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.

Biological: VSV-02 Injection

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.

VSV-02 Dose Escalation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary signed informed consent.
• Age ≥ 18 years.
• Histologically or cytologically confirmed advanced solid tumor (e.g., melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer).
• Disease progression after at least two prior lines of standard therapy (including targeted therapy), or for whom no standard therapy exists or is medically unsuitable.
• At least one measurable lesion per RECIST 1.1 criteria.
• At least one lesion accessible for intratumoral injection.
• ECOG performance status of 0-2.
• Life expectancy ≥ 12 weeks.
• Adequate organ and bone marrow function.
• Negative pregnancy test for women of childbearing potential.
• Agreement to use effective contraception during the study and for at least 6 months after the last dose.

You may not qualify if:

• Symptomatic or untreated brain metastases (asymptomatic or stable for ≥3 months after local therapy allowed).
• Radiotherapy to the target lesion within 2 months.
• History of other active malignancy within 5 years (with specific exceptions).
• Lesion intended for injection with a longest diameter \> 100 mm.
• Participation in another interventional clinical trial within 4 weeks.
• Prior or planned organ/tissue transplantation.
• Active HIV, Hepatitis B, Hepatitis C, or Syphilis infection meeting specific criteria.
• Requirement for concomitant antiviral or therapeutic anticoagulation.
• Uncontrolled ≥ Grade 3 active infection.
• Specific washout periods for prior anti-cancer therapies not met.
• Uncontrolled cardiovascular disease.
• Active or history of autoimmune disease (with specific exceptions).
• Requirement for systemic corticosteroids (\>10 mg prednisone equivalent) within 14 days or during the study.
• Tumors located in high-risk anatomical sites.
• Administration of live vaccines during the study period.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

RECRUITING

MeSH Terms

Conditions

Melanoma; Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Breast Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• LiuZhong Yang, master

  First Affiliated Hospital of Xinjiang Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LiuZhong Yang, master

CONTACT

8613639638824; 56236053@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: December 3, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)