Phase 1 First-in-Human Multi-Region Clinical Trial of ORM-1153 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Other Hematological Malignancies With CD123 Expression
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Optimal Biological Dose(s) of ORM-1153
研究概览
简要总结
The goal of this Phase 1 clinical trial is to understand whether a new experimental treatment, called ORM-1153, will be a safe and possibly effective treatment option for participants with blood cancers such as Acute Myeloid Leukemia (AML) which have a particular protein (called Cluster of Differentiation 123 or CD123) on the cancer cell's surface. Phase 1 studies are designed to find a safe and effective dose.
Participants will be receiving ORM-1153 at the defined study frequency as an infusion into the vein. They will need to visit the clinic frequently during the first few months of treatment.
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
- •Adults ≥18 years of age (or ≥19 years of age according to local regulatory guidelines) at the time of signature of the informed consent form.
- •Documented diagnosis of relapsed or refractory AML with any detectable level of CD123 as evaluated by local assessment.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- •Adequate organ and coagulation function.
排除标准
- •Diagnosed with Acute Promyelocytic Leukemia.
- •Systemic antineoplastic agent therapy given within 14 days or 5 half-lives prior to the first dose of ORM-1153 (whichever is shorter).
- •Hematopoietic Stem Cell Transplantation within 3 months of the first dose of ORM-
- •Total White Blood Cell count >25,000/µL.
研究组 & 干预措施
Part 1 Dose Escalation
All participants receive ORM-1153 in escalating dose cohorts in Phase 1 Dose Escalation.
干预措施: ORM-1153 (Drug)
结局指标
主要结局
Optimal Biological Dose(s) of ORM-1153
时间窗: Approximately 24 months
Identify the Dose-limiting Toxicities for each dose level tested and determine the OBD(s) of ORM-1153
Incidence of Dose Limiting Toxicities (DLTs)
时间窗: Approximately 24 months
Evaluate the safety and tolerability of ORM-1153 by identifying the DLTs
Incidence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Approximately 24 months
Evaluate the safety and tolerability of ORM-1153 by identifying TEAEs
次要结局
- Area Under the Serum Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of ORM-1153, total antibody and the payload(Approximately 36 months)
- Overall Response Rate (ORR) of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Duration of Response (DoR) of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Best Overall Response (BOR) of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- CR with Partial (CRh) and Incomplete (CRi) Recovery of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Event Free Survival (EFS) of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Relapse Free Survival (RFS) of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Overall Survival (OS) of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Transition Rate to Allogeneic Hematopoietic Stem Cell Transplantation of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- GSPT1 Protein Degradation and CD123 Receptor Occupancy of ORM-1153 at various dose levels including OBD(s)(Approximately 36 months)
- Study the anti-drug antibodies against ORM-1153(Approximately 36 months)
- Maximum Observed Serum Concentration (Cmax) of ORM-1153, total antibody and the payload(Approximately 36 months)
- Time to Maximum Observed Serum Concentration (Tmax) of ORM-1153, total antibody and the payload(Approximately 36 months)