NCT07067346招募中1 期
A Study to Evaluate Safety and Efficacy of Radiopharmaceutical IR-101 in Patients With Relapsed or Refractory Neuroblastoma
Sichuan University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence and severity of dose-limiting toxicities (DLTs)
研究概览
简要总结
Radiopharmaceutical in Relapsed/Refractory Neuroblastoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory high-risk neuroblastoma with MIBG avid lesions in accordance with the Revised International Neuroblastoma Response Criteria (INRC);
- •All soft-tissue lesions detected on CT/MRI must be MIBG-avid;
- •Age ≥12 months;
- •Lansky performance status ≥50%;
- •Adequate organ function and hematologic parameters;
排除标准
- •Antibody-based immunotherapy within 5 half-lives or 30 days (whichever is shorter), or not yet recovered from adverse reactions of prior biologic therapies；
- •Treatment with [¹³¹I]MIBG or Lu-177 targeted radionuclide therapy <3 months of last administration;
- •Autologous transplant <12 weeks, or Allogeneic transplant <4 months (patients >4 months post-transplant must be free of active GVHD);
- •Radiotherapy within 2 weeks prior to first dose of study drug (However, if the subjects undergone radiotherapy for the sole lesion have MIBG uptake after 2 weeks of radiotherapy completion, they will be eligible); or Extensive-field radiotherapy (e.g., Cranio-spinal cord, whole lung, whole abdomen, or >50% bone marrow) within 12 weeks prior to first dose of study drug;
- •Renal Insufficiency;
- •Active Infections;
研究组 & 干预措施
Dose Escalation
Experimental
Study drug IR-101 Dose Escalation
干预措施: IR-101 (Drug)
结局指标
主要结局
Incidence and severity of dose-limiting toxicities (DLTs)
时间窗: From administration of IR-101 until 4 weeks after injection
Incidence and severity of dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
时间窗: From administration of IR-101 until 4 weeks after last dose of injection
Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
次要结局
- Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)(4 weeks after IR-101 administration)
- Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry(About 21hours from time of IR-101 administration)
研究者
Rong Tian
Director
Sichuan University
研究点 (1)
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