VSV-02 for advanced solid tumors
Official title: A Single-Arm, Open-Label, Compassionate Use Study of VSV-02 Administered Intravenously and Intratumorally in Patients With Advanced Solid Tumors
Run by The First Affiliated Hospital of Xinxiang Medical College · NCT07260591 · Data updated 2026-11-12
This treatment will try VSV-02 given into a vein and directly into tumors to see if it helps people with advanced solid tumors who have limited treatment options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 6 (estimated) |
| Sponsor | The First Affiliated Hospital of Xinxiang Medical College Academic / other |
| Drugs / interventions | prednisone, chemotherapy, Immunotherapy |
| Locations | 1 site (Xinxiang, Henan) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT07260591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed advanced solid tumors who progressed after at least two prior standard therapies or have no suitable standard options, with at least one measurable and intratumorally accessible lesion, ECOG 0–2, and adequate organ function.
✕Probably not a fit
Patients with symptomatic or untreated brain metastases, poor performance status, no lesions accessible for intratumoral injection, or who are pregnant/breastfeeding are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
VSV-02 is an engineered vesicular stomatitis virus designed to infect and lyse tumor cells and locally produce a CD3/PD-L1 bispecific antibody to recruit and activate T cells. This open-label, single-arm Phase 1 study gives VSV-02 intravenously and by intratumoral injection on day 1 of each 3-week cycle for up to six cycles using a dose-escalation design. Researchers will measure tumor responses (ORR, DCR, DoR), progression-free and overall survival per RECIST 1.1, and closely monitor safety and tolerability. Eligible patients must have advanced solid tumors with at least one measurable and injectable lesion and limited or no standard treatment options.
Why it matters
Potential benefit: If successful, VSV-02 could directly destroy injected tumors and stimulate a localized immune response that helps control metastatic disease and overcome PD‑1/PD‑L1 resistance.
How similar studies have gone: Oncolytic virus therapy (for example T‑VEC) has shown benefit in melanoma, but VSV-based vectors delivering a CD3/PD-L1 bispecific antibody are a novel approach with limited clinical data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China Recruiting
Study contacts
- Principal investigator: LiuZhong Yang, master — First Affiliated Hospital of Xinjiang Medical University
- Study coordinator: LiuZhong Yang, master
- Email: 56236053@qq.com
- Phone: 8613639638824
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.