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New treatment option for Advanced Solid Tumor
Official title VSV-02 Compassionate Use in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07260591
What this study is testing
What is VSV-02 Injection?
VSV-02 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Disease progression after at least two prior lines of standard therapy (including targeted therapy), or for whom no standard therapy exists or is...
- At least one measurable lesion per RECIST 1.1 criteria.
You likely can't join 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 treatment clinical trial within 4 weeks.
- Prior or planned organ/tissue transplantation.
See the full eligibility criteria
- 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...
- 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.
- 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 treatment 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.
- Known hypersensitivity to any component of the study drug or related immunotherapies.
- History of severe mental illness, substance abuse, or other conditions that may interfere with study compliance.
- Pregnancy or lactation.
- Toxicities from previous anti-cancer therapy not recovered to ≤ Grade 1 (except alopecia).
- Any other condition deemed inappropriate for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Xinxiang, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xinxiang, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.