NCT07173595招募中1 期
A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of QLS2309 Injection in Patients With CD70+ Relapsed/Refractory Hematologic Malignancies
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
- 186
- 试验地点
- 1
- 主要终点
- Recommended Phase Ib Dose (RPIbD)
研究概览
简要总结
This is a single-arm, open-label, multicenter, dose-escalation, dose-expansion and efficacy-expansion phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary antitumor activity of QLS2309 injection in patients with CD70+ relapsed/refractory hematologic malignancies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subjects voluntarily participated and signed a written informed consent form
- •Age ≥ 18 years, male or female
- •ECOG performance status of 0-2
- •Expected life-expectancy ≥ 3 months
- •CD70+ relapsed/refractory hematologic malignancies
- •Adequate organ function prior to QLS2309 administration
- •Female patients with fertility must agree to the use of effective contraceptive methods during the study period and within 35 days of discontinuation of the trial drug.
- •Male patients whose sexual partners are women of childbearing age must agree to use condoms during the study period and within 35 days of discontinuation of the trial drug during sexual intercourse.
排除标准
- •Prior treatment with CD70-related antibodies, antibody-conjugated drugs (ADCs) or cell therapy products
- •Symptomatic central nervous system (CNS) involvement, leptomeningeal metastasis or spinal cord compression caused by metastasis
- •An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
- •Known history of other active malignant tumor within 3 years
- •Known history of chemotherapy, biological therapy, endocrine therapy, immunotherapy, monoclonal antibodies, etc. within 4 weeks
- •Known history of active hepatitis B/C infection, HIV infection, Treponema pallidum infection
研究组 & 干预措施
QLS2309
Experimental
干预措施: QLS2309 (Drug)
结局指标
主要结局
Recommended Phase Ib Dose (RPIbD)
时间窗: up to 2 years
The Safety Monitoring Committee (SMC) will select RP1bD based on the safety, tolerability, PK parameters, pharmacodynamics, preliminary effectiveness and other data of subjects in different dose groups
Dose-limiting toxicity(DLT)
时间窗: 28 days
To evaluate the safety and tolerability of QLS2309
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Phase III Study of 2 doses of V503 in 9 to 14 year-olds Compared to Young WomeThis study is to study the tolerability and immunogenicity of V503, specific conditions (effiecacy endpoints) are not being investigated in this study.EUCTR2013-001314-15-CZMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.1,500
进行中（未招募）
1 期
A Study for V503 in 16- to 26-Year-Old Men and 16- to 26-Year-Old WomeEUCTR2012-002758-22-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc2,520
进行中（未招募）
不适用
A Study for V503 in 16- to 26-Year-Old Men and 16- to 26-Year-Old WomeEUCTR2012-002758-22-DEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc2,500
进行中（未招募）
不适用
A Study for V503 in 16- to 26-Year-Old Men and 16- to 26-Year-Old WomePrevention of external genital lesions, anal cancers and related precancers, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58.EUCTR2012-002758-22-SEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc2,500
进行中（未招募）
1 期
A Study for V503 in 16- to 26-Year-Old Men and 16- to 26-Year-Old WomePrevention of external genital lesions, anal cancers and related precancers, and persistent infection caused by Human Papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58.EUCTR2012-002758-22-DKMerck & Co. Inc.2,520