NCT03529539No Longer Available不适用
Expanded Access for PSV Personalized Oncolytic Viruses
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
研究概览
简要总结
A compassionate use, expanded access protocol for patients who have exhausted all standard therapy having progressed on chemotherapy and immunotherapy.
详细描述
Patients will receive intratumoral or subcutaneous injection of an oncolytic virus called PSV (short for Personalized Virus) every other week until the occurrence of immune related RECIST progression, intolerable toxicity, change to another anti-cancer treatment due to lack of apparent benefit, or personal choice.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and sign a written informed consent form.
- •Measurable or evaluable disease with least one (1) tumor that is accessible to intratumoral injection.
- •Eastern Cooperative Group (ECOG) performance status is 0-3 at Screening.
- •Acceptable liver function at Screening, as evidenced by:
- •Bilirubin ≤ 3.0 X upper limit of normal (ULN) since this patient has
- •been diagnosed with Gilbert's Disease
- •AST (SGOT) and ALT (SGPT) ≤ 5 X ULN.
- •Serum creatinine < 3 x institution upper limit of normal.
- •Patient has acceptable hematologic status at Screening, as evidenced by:
- •Absolute neutrophil count ≥ 1,500 cells/mm3; and
- •Platelet count ≥ 70,000/mm3; and
- •Hemoglobin (HGB) ≥ 8.5 g/dL.
- •Medically acceptable contraception.
- •Willingness to comply with all protocol procedures, evaluations and rescue measures.
排除标准
- •Presence of a serious co-morbid medical condition, or a clinically significant laboratory finding(s) that, in the opinion of the Investigator, suggests the presence of an infectious, endocrine, and/or other inadequately treated systemic disorder.
- •An active bacterial, fungal, or viral infection.
研究者
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