Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT07260591

VSV-02 Compassionate Use in Advanced Solid Tumors

Led by The First Affiliated Hospital of Xinxiang Medical College · Updated on 2025-12-03

6

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

VSV-02 Compassionate Use in Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary signed informed consent
  • Age 18 years or older
  • Advanced solid tumor confirmed by histology or cytology (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 or no suitable standard therapy available
  • At least one measurable tumor lesion per RECIST 1.1
  • At least one lesion accessible for intratumoral injection
  • ECOG performance status of 0 to 2
  • Life expectancy of at least 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 last dose
Not Eligible

You will not qualify if you...

  • Symptomatic or untreated brain metastases (asymptomatic or stable for at least 3 months after local therapy allowed)
  • Radiotherapy to the target lesion within 2 months prior to enrollment
  • History of other active malignancy within 5 years (with exceptions)
  • Lesion intended for injection larger than 100 mm in longest diameter
  • Participation in another interventional clinical trial within 4 weeks
  • Prior or planned organ or tissue transplantation
  • Active HIV, Hepatitis B, Hepatitis C, or Syphilis infection meeting specific criteria
  • Requirement for antiviral or therapeutic anticoagulation treatment
  • Uncontrolled active infection of Grade 3 or higher
  • Inadequate washout periods from prior anti-cancer therapies
  • Uncontrolled cardiovascular disease
  • Active or history of autoimmune disease (with specific exceptions)
  • Use of systemic corticosteroids over 10 mg prednisone equivalent within 14 days or during study
  • Tumors located in high-risk anatomical sites
  • Administration of live vaccines during the study
  • Known hypersensitivity to study drug components or related immunotherapies
  • History of severe mental illness, substance abuse, or conditions interfering with study compliance
  • Pregnancy or lactation
  • Unresolved toxicities from prior anti-cancer therapy greater than Grade 1 (except alopecia)
  • Any other condition deemed inappropriate for participation by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Actively Recruiting

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Research Team

L

LiuZhong Yang, master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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