VSV-02 Compassionate Use in Advanced Solid Tumors

Korábbi kezelés

• Symptomatic or untreated brain metastases (asymptomatic or stable for ≥3 months after local therapy allowed).
• Radiotherapy to the target lesion within 2 months.
• Prior or planned organ/tissue transplantation.
• Requirement for concomitant antiviral or therapeutic anticoagulation.
• Specific washout periods for prior anti-cancer therapies not met.
• Requirement for systemic corticosteroids (\>10 mg prednisone equivalent) within 14 days or during the study.
• Administration of live vaccines during the study period.
• Toxicities from previous anti-cancer therapy not recovered to ≤ Grade 1 (except alopecia).

Más betegség

• History of other active malignancy within 5 years (with specific exceptions).
• Active HIV, Hepatitis B, Hepatitis C, or Syphilis infection meeting specific criteria.
• Uncontrolled ≥ Grade 3 active infection.
• Uncontrolled cardiovascular disease.
• Active or history of autoimmune disease (with specific exceptions).
• 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.
• Any other condition deemed inappropriate for participation by the investigator.

Egyéb

• Lesion intended for injection with a longest diameter \> 100 mm.
• Participation in another interventional clinical trial within 4 weeks.
• Tumors located in high-risk anatomical sites.
• Pregnancy or lactation.

• 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.