VSV-02 Compassionate Use in Advanced Solid Tumors

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 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.

Eligibility

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.

Conditions7

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