NCT06359002进行中（未招募）1 期
A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Byondis B.V.
- 入组人数
- 16
- 试验地点
- 9
- 主要终点
- Incidence of dose-limiting toxicities (dose escalation)
研究概览
简要总结
This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.
详细描述
This trial includes two parts. Part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of BYON4413 will be determined. Part 2 is an expansion study to evaluate the anti-leukemia activity and safety of BYON4413.
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
- •Patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of:
- •R/R AML (WHO 2022) OR
- •MDS (WHO 2022) with ≥10% blasts in BM and have received ≥3 cycles of HMA
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
- •Adequate baseline organ function.
排除标准
- •Having been treated with any CD123-targeting therapies;
- •Having received allogeneic hematopoietic stem cell transplantation within 100 days prior to start Cycle 1 Day 1;
- •Having treatment-related toxicities from prior anti-leukemia therapies that have not resolved to CTCAE Grade ≤ 1;
- •Having active central nervous system AML or AML of the APL/M3 subtype;
- •History of keratitis;
- •History of specified lung or renal disease;
- •Having clinically significant cardiovascular disease;
- •Known infection of Hepatitis B, C or E.
- •Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
研究组 & 干预措施
Dose Escalation
Experimental
Escalating dose cohorts of BYON4413 for patients with AML or MDS.
干预措施: BYON4413 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (dose escalation)
时间窗: 21 days
Composite Complete Remission Rate (expansion)
时间窗: Up to 24 months
CR + CRh + CRi according ELN 2022 criteria
次要结局
- Relapse-free survival(Up to 24 months)
- Incidence and severity of adverse events(Up to 24 months)
- Maximum Plasma Concentration (Cmax) BYON4413(Up to 24 months)
- Percentage of blasts in bone marrow change from baseline(Up to 24 months)
- Number of patients with dose modifications(Up to 24 months)
- Time to Cmax (Tmax) BYON4413(Up to 24 months)
- Percentage of patients with confirmed anti-BYON4413 antibodies(Up to 24 months)
- Objective response rate(Up to 24 months)
- Time to response(Up to 24 months)
- Overall survival(Up to 24 months)
- Percentage of blasts in peripheral blood change from baseline(Up to 24 months)
- Event-free survival(Up to 24 months)
- Rate of early death(Within 3 treatment cycles)
- Area under the curve (AUC) BYON4413(Up to 24 months)
- Composite Complete Remission Rate (dose escalation)(Up to 24 months)
- Duration of response(Up to 24 months)
研究者
研究点 (9)
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