NCT06086522招募中1 期
A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors
Qualigen Theraputics, Inc.4 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年11月1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
- 54
- 试验地点
- 4
- 主要终点
- Determine MTD
研究概览
简要总结
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer).
Main questions:
- What does the study drug do to human body (Pharmacodynamics [='PD'])
- What does the body do to study drug (how processed in body (Pharmacokinetics [='PK']) - Safety
Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.
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
- •Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy
- •Evaluable or measurable disease by RECIST 1.1
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Other
Starting dose in Phase 1a dose escalation
干预措施: QN-302 (Drug)
Cohort 2
Other
2nd cohort in Phase 1a dose escalation
干预措施: QN-302 (Drug)
结局指标
主要结局
Determine MTD
时间窗: 18 months
maximum tolerated dose identified from dose escalation cohorts
Establish RP2D
时间窗: 24 months
recommended Phase 2 dose identified from dose escalation cohorts
次要结局
未报告次要终点
研究者
研究点 (4)
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