NCT07165132招募中1 期
Phase 1 First-in-Human, Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225, in Subjects With Neuroendocrine Tumors and Other Solid Tumors Expressing Somatostatin Receptors.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 15
- 主要终点
- Dose Escalation
研究概览
简要总结
The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old at the time of signing the main study informed consent form (ICF).
- •Histologically confirmed:
- •Dose Escalation (all cohorts): Grades 1-3 WD, metastatic or locally advanced and unresectable NET at any primary site, including, but not limited to, GI, pancreatic, lung, thyroid, breast, urogenital, and adrenal tumors.
- •Dose Expansion Cohort A: Grades 1-3 WD, metastatic or locally advanced and unresectable GEP-NETs
- •Dose Expansion Cohort B: metastatic or locally advanced and unresectable tumors known to frequently express SSTR, limited to the following indications:
- •WD NETs (Grades 1-3) from primary sites other than gastrointestinal and pancreatic (including, but not limited to, lung, thyroid, breast, urogenital, and adrenal tumors) Meningioma (Grades 1-3)
- •SSTR-positive disease, as assessed by SSTR-PET imaging
- •Adequate renal, hematologic and hepatic function
排除标准
- •Prior RPT, including Lu-
- •Prior solid organ or bone marrow transplantation.
- •Use of chronic systemic steroid therapy.
- •Significant cardiovascular disease
- •Resistant hypertension
- •Uncontrolled diabetes
- •Prior history of liver cirrhosis
- •HIV, hepatitis B infection or known active hepatitis C virus infection.
- •Note: Additional criteria may apply and will be assessed by the study site
研究组 & 干预措施
Dose Escalation, Dose Expansion
Experimental
干预措施: RYZ401 (Drug)
结局指标
主要结局
Dose Escalation
时间窗: Incidence of DLTs during the first 4 weeks of RYZ401 treatment
Incidence of DLTs during RYZ 401 Treatment
Dose Expansion
时间窗: Cycle1 Day 1 to LPFV + 6 weeks
Incidence, severity, and duration of AEs
次要结局
未报告次要终点
研究者
研究点 (15)
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