NCT06590961招募中1 期
A Phase Ia/Ib, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic of UBX-303061 in Subjects With Relapsed/Refractory B-Cell Malignancies
Ubix Therapeutics, Inc.11 个研究点 分布在 3 个国家目标入组 94 人开始时间: 2025年2月20日最近更新:
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
- 94
- 试验地点
- 11
- 主要终点
- Number of subjects with Protocol Specified Dose-Limiting Toxicities
研究概览
简要总结
This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
UBX-303061
Experimental
UBX-303061
干预措施: UBX-303061 (Drug)
结局指标
主要结局
Number of subjects with Protocol Specified Dose-Limiting Toxicities
时间窗: 28-days
Phase 1a and 1b
To establish the maximum tolerated dose and/or recommended Phase 1b dose(s)
时间窗: Up to End of Treatment (up to 9 months)
Phase 1a and 1b
Number of subjects with dose interruptions, reductions, and doses administered
时间窗: Up to End of Treatment (up to 9 months)
Phase 1a and qb
次要结局
- To evaluate the anti-tumor activity of UBX-303061 in the dose levels based on Best overall response(Up to End of Treatment (up to 9 months))
- To assess genetic markers including but not limited to BTK, PLCG2, MYD88(Up to End of Treatment (up to 9 months))
- To assess Cmin(28-days)
- To assess tmax(28-days)
- To assess AUC(28-days)
- To assess Cmax(28-days)
研究者
研究点 (11)
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