Expanded Access to RZ-001 in Combination with Valganciclovir in the Treatment of Subjects with Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 1
研究概览
简要总结
This small-size patient population expanded access program is to provide access to investigational product RZ-001 for up to around 4 patients with human telomerase reverse transcriptase(hTERT)-positive Glioblastoma (GBM) who are not eligible to participate in the RZ-001-201 clinical study or in any other study involving the use of RZ-001
详细描述
This expanded access protocol provides expanded access to RZ-001 to patients with glioblastoma. After provision of written informed consent, subjects will be evaluated for eligibility during the Screening period, a period of 28 days prior to the RZ-001 administration on Day 1. Subjects will then undergo treatment, 8 weeks of follow-up, and bimonthly or quarterly (after 6 months from RZ-001 administration) survival follow-up.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females legally considered to be adults in the country in which they are participating in the study.
- •Histologically-confirmed Grade 4 astrocytoma, GBM, per The 2021 WHO Classification of central nervous system (CNS) Tumors.
- •Recurrent GBM with radiographic evidence of the PD (progressive disease) which contains measurable disease (≥ 1 cm bidirectional diameters) by contrast-enhancement on MRI, as defined by the mRANO (modified Response Assessment in Neuro-Oncology) criteria. Only localized unifocal or multifocal recurrence is allowed, while other type of recurrences such as intraventricular, diffuse recurrence are not allowed.
排除标准
- •Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.
- •Have received chemotherapy within 4 weeks, and/or immunomodulatory therapy, immunotherapy, antibody therapy, gene vector therapy, vaccine therapy, and/or matrix metalloprotease inhibitor(s) within 3 months from Screening.
- •Have received radiotherapy within 12 weeks from Screening.
- •Have extracranial metastases of the tumor cells.
- •The subject is eligible for participation in any ongoing clinical study with RZ-001, or has already received RZ-001 in the past.
- •The subject is being transferred from an ongoing clinical study for which they are still eligible.