JPRN-jRCT2080222883未知1 期
A Phase I Study of Repeated Intratumoral Administration of TBI-1401(HF10), a Replication Competent HSV-1 Oncolytic Virus, in Patient With Solid Tumors With Superficial Lesions
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients must have histologically confirmed solid tumors with superficial lesions (>=10mm).
- •2) Patients must have unresectable and standard therapies-resistant solid tumors.
- •3) Patients must have a life expectancy >=12 weeks.
- •4) Patients must have measurable non-visceral lesion(s) that are evaluable by the mWHO response criteria.
- •5) Patients must have an ECOG performance status of 0,1, or 2.
- •6) Patients must have adequate organ function (bone marrow, heart, lung, liver, renal, etc) and must meet all the following criteria.
- •- Absolute neutrophil count >=1,500/uL.
- •- Platelet count >=100,000/uL.
- •- Total bilirubin levels =<1.5 x upper limit of normal (ULN).
- •- AST/ALT levels =<2.5 x ULN, or =<5 x ULN if liver metastases are present.
- •- creatinine =<1.5 x ULN. (creatinine clearance (calculated) >=60mL/min/1.73m^2 for patients with creatinine >1.5 x ULN).
- •7) Patients must have passed 4 weeks after the completion of prior therapy [except bone metastasis therapy], or passed 8 weeks if immuno checkpoint inhibitor was treated.
- •8) Patients must be able to understand and willing to sign a written informed consent document.
排除标准
- •1) Patients with a significant risk of tumor bleeding, or coagulation or bleeding disorders.
- •2) Patients with >=Grade 2 adverse events except for alopecia related to the prior therapy, which was performed 4 weeks or more before the scheduled date of TBI-1401(HF10) administration(Except for case in which adverse event caused by previous treatment is controlled by medication etc. and the investigator judges that the adverse event exerts on safety evaluation).
- •3) Patients receiving anti-herpes medication (except local treatment such as ointment).
- •4) Patients receiving systemic administration of steroids or immunosuppressive agents (except for steroid inhalation).
- •5) Patients positive for HBs antigen, HCV antibody or HIV antibody.
- •6) Patients receiving anti-platelet medication, which is difficult to be discontinued during the clinical trial.
- •7) Patients receiving anti-coagulation medication by which intratumoral injection or biopsy cannot be conducted safely.
- •8) Patients with presence or medical history of central nervous system metastasis.
- •9) Patients with Grade >=1 pre-existing neurologic abnormalities.
- •10) Patients with severe cardiac disorder or abnormal cardiac rhythm.
- •11) Patients with psychiatric disorder or drug dependency which affects informed consent.
- •12) Pregnant or breastfeeding women (except for the case of discontinuation without resumption); women or men, having normal reproductive potential, who disagree with contraception according to physician's instruction within the timeframe of the study.
- •13) Patients received any other investigational products within 4 weeks, or within 8 weeks if immuno checkpoint inhibitor was treated.
- •14) Any other patients judged by investigators to be inappropriate for the subject of this study.
研究者
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