VSV-02 Compassionate Use in Advanced Solid Tumors
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, si
| Condition(s) | Advanced Solid Tumor, Melanoma, Breast Cancer, Lung Cancer, Cancer Treatment, Immunotherapy |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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 pat |
| Who can participate | 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 con |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Xinxiang Medical College |
| Locations | Xinxiang, Henan, China |
| Start date | 2025-09-22 |
| NCT ID | NCT07260591 |
| Official listing | https://clinicaltrials.gov/study/NCT07260591 |