211At-MABG in Adults With Advanced Neuroendocrine Cancers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Evaluate study feasibility overall study feasibility assessed for operational issues versus treatment-related adverse events.
研究概览
简要总结
Phase I dose escalation study of 211At-MABG in adults with advanced pheochromocytoma / paraganglioma (PPGL) or other NET-overexpressing cancers (as evidenced by positive MIBG imaging) who are refractory to, lacking, or ineligible for approved treatments. Phase 1 dose-escalation will follow a standard 3+3 design with an expansion cohort at the recommended phase two dose (RP2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients, at least 18 years of age
- •Advanced neuroendocrine cancers requiring systemic therapy and refractory to, ineligible for, declining, or lacking standard treatments.
- •I MIBG imaging indicating MIBG-avid disease (radiotracer uptake above background in at least one tumor site) per Investigator/Sub-Investigator assessment.
- •Participants must provide written informed consent prior to study-specific procedures.
- •ECOG performance status ≤
- •Adequate organ function including:
- •Hemoglobin ≥ 9 g/dL
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 75,000/mm³
- •Measured or estimated GFR ≥ 60 mL/min
- •Serum bilirubin ≤ 1.5x upper limit of normal
- •ALT/AST each ≤ 2.5x upper limit of normal
- •Life expectancy at least 3 months as judged by treating physician
排除标准
- •Women who are pregnant or breast-feeding will not be eligible for this study.
- •Inability to tolerate study procedures in the opinion of the investigator or treating physician.
- •Serious or unstable medical, psychological, or social conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
- •Uncontrolled brain metastasis (Participant must be at least 4 weeks since CNS-directed therapy and no longer requiring corticosteroid therapy).
- •Anticancer therapy, except hormonal therapy or bone supportive therapies, within 14 days of cycle 1 day
- •Has a known additional malignancy (other than the disease under study) that has required active systemic treatment within the past 2 years AND for which the natural history or recent/ongoing treatment could likely interfere with study endpoints or safety of the study treatment per Investigator and Medical Director assessment.
研究组 & 干预措施
Dose Level -1: Fractionated 211At-MABG
One treatment cycle (1 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (0.25 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses).
干预措施: 1 MBq/k of 211At-MABG Fractionated (Drug)
Dose Level 1: Fractionated 211At-MABG
One treatment cycle (2 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (0.5 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses).
干预措施: 2 MBq/k1 of 211At-MABG Fractionated (Drug)
Dose Level 2: Fractionated 211At-MABG
One treatment cycle (4 MBq/k) of 211At-MABG administered by IV administration in 4 fractionated (1 MBq/kg) weekly doses (+ 7 days) (one treatment cycle = 4 weekly fractionated doses).
干预措施: 4 MBq/k of 211At-MABG Fractionated (Drug)
结局指标
主要结局
Evaluate study feasibility overall study feasibility assessed for operational issues versus treatment-related adverse events.
时间窗: 4 weeks
Proportion of fractionated dose administrations either delayed and/or omitted due to operational issues (i.e. insufficient/delayed synthesis) versus treatment-related adverse events (at the overall study level).
Evaluate overall study feasibility
时间窗: 4 weeks
Proportion of intended 211At-MABG fractionated doses that are successfully administered within the protocol-defined window (at the overall study level).
次要结局
- Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per patient level(4 weeks)
- Safety of fractionated dosing of 211At-MABG in adults with advanced (PPGL) or other NET-overexpressing cancers per 'dose level'.(4 weeks)
- The maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D) of 211At-MABG(8 weeks)
- Incidence of Adverse Events(72 months)
- The objective response rate (ORR) per RECIST 1.1 following a single cycle of fractionated dosing of 211At-MABG(72 months)
- The duration of response (DOR) following a single cycle of fractionated dosing of 211At-MABG(12 months)
- The Disease Control Rate (DCR) following a single cycle of fractionated dosing of 211At-MABG(12 months)
- Biochemical Response (BCR)(12 months)
- Anti-Hypertensive Medication Response(12 months)
- The time to subsequent anti-cancer therapy (time to next treatment) (TTNT)(12 months)