NCT06980116招募中1 期
A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.20 个研究点 分布在 7 个国家目标入组 85 人开始时间: 2025年3月31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
- 入组人数
- 85
- 试验地点
- 20
- 主要终点
- Number of Participants with Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed/refractory B-cell 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
- •Age ≥18 years at the time of signing the informed consent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.
- •Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy
排除标准
- •Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
- •Known central nervous system (CNS) malignancy or primary CNS lymphoma.
- •Concurrent active or previous malignancy (other than the primary lymphoma/CLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.
- •Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
研究组 & 干预措施
EXS73565
Experimental
干预措施: EXS73565 (Drug)
结局指标
主要结局
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 282 days
Dose-limiting toxicities (DLTs) of EXS73565-001
时间窗: Up to 21 days
次要结局
- Time to Maximum Concentration (Tmax) of EXS73565-001(Up to 253 days)
- Area Under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration AUC(0-last) of EXS73565-001(Up to 253 days)
- Maximum Concentration (Cmax) of EXS73565-001(Up to 253 days)
- Overall Response Rate (ORR)(Up to 434 days)
- Disease Control Rate(Up to 434 days)
- Progression Free Survival(Up to 434 days)
- Duration of Response(Up to 434 days)
- Time to Respond(Up to 434 days)
- Time to Progression(Up to 434 days)
研究者
研究点 (20)
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