NCT07767630招募中1 期
An Exploratory Proof-of-Concept (POC) Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Fractionated Dosing of [211At]MABG in Patients With Relapsed or Refractory Neuroblastoma (Including a Run-in Phase)
Sichuan University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月21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
Fractionated dosing of [211At]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
详细描述
Fractionated dosing of [211At]MABG Radiotherapy in Relapsed/Refractory Neuroblastoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease.
- •All measurable soft tissue lesions must be MIBG-avid.
- •Age ≥ 1 year at enrollment.
- •Lansky performance status ≥ 50%.
- •Adequate organ function and hematologic parameters.
排除标准
- •Antibody-based immunotherapy within fewer than 5 half-lives or 30 days (whichever is shorter), or who have not yet recovered from adverse effects of any biologic therapy.
- •Treatment with [¹³¹I]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration.
- •Autologous stem cell transplant <12 weeks, or Allogeneic stem cell transplant <4 months (patients >4 months post-transplant must be free of active GVHD).
- •Radiotherapy within 2 weeks prior to the first study dose (However, patients with a single-site irradiation that remains MIBG avid may be enrolled.) or extensive-field radiotherapy (e.g., craniospinal, whole abdomen, whole lung, or >50% of bone marrow area) within 12 weeks prior to the first study dose.
- •Renal Insufficiency.
- •Active Infections.
研究组 & 干预措施
[211At]MABG
Experimental
Fractionated Dose
干预措施: [211At]MABG (Drug)
结局指标
主要结局
Incidence and severity of dose-limiting toxicities (DLTs)
时间窗: From administration of [211At]MABG 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 [211At]MABG 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)(Around 8 weeks after 1st [211At]MABG administration)
- Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry(About 21hours from time of [211At]MABG administration])
- Response assessed in accordance with the Revised International Neuroblastoma Response Criteria (INRC)(8 weeks after [211At]MABG administration, Participants without disease progression (PD) will be evaluated every 8 weeks for the first 24 weeks, then every 12 weeks until PD, new cancer therapy, death, or study termination)
研究者
Rong Tian
Professor
Sichuan University
研究点 (1)
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