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

VSV-02 Compassionate Use in Advanced Solid Tumors (NCT07260591) is a Phase 1 interventional studying Advanced Solid Tumor and Melanoma, sponsored by The First Affiliated Hospital of Xinxiang Medical College. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 6 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Voluntary signed willing to sign a consent form. Age ≥ 18 years. diagnosed by tissue sample (biopsy-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. You should be able to carry out daily activities with 0 level of ability (ECOG 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. Who Should NOT Join This Trial: 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 waiting period after previous treatments for prior anti-cancer therapies not met. Uncontrolled cardiovascular disease. Active or history of autoimmune conditions (where your immune system attacks your own body) (with specific exceptions). Requirement for systemic corticosteroids (\>10 mg prednisone equivalent) within 14 days or during the study. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion 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 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. Exclusion Criteria: 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. 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.

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07260591), the sponsor (The First Affiliated Hospital of Xinxiang Medical College), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07260591 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07260591?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07260591?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07260591. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07260591. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.