A Phase 1, First-in-Human, Dose Escalation Study of JNJ-89853413 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 12
- 主要终点
- Number of Participants with Adverse events (AEs) by Severity
研究概览
简要总结
The purpose of Part 1 (Dose Escalation) of the study is to assess the safety and tolerability, and to identify the recommended Phase 2 dose[s] (RP2D[s]) in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) (that is a type of blood cancer that has come back after treatment/or has stopped responding to treatment) or R/R higher-risk type of myelodysplastic neoplasms (MDS, type of blood cancer). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS.
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
- •Have a diagnosis, per World Health Organization (WHO) 2022 criteria of:
- •relapsed/refractory acute myeloid leukemia (AML)
- •relapsed/refractory moderate high, high, or very high risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M)
- •Body weight greater than or equals to (>=) 40 kilograms (kg)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- •Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) >=40 milligrams per minute (mL/min)
- •Participants must have laboratory parameters in the required range
排除标准
- •Has a medical history of clinically significant pulmonary compromise, particularly the need for current supplemental oxygen use to maintain adequate oxygenation
- •Has evidence of an uncontrolled systemic viral, bacterial, or fungal infection
- •Has known allergies, hypersensitivity, or intolerance to the excipients of JNJ-89853413
- •Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-89853413
- •Has known active central nervous system involvement
研究组 & 干预措施
JNJ-89853413
Participants will receive JNJ-89853413 in Part 1 (Dose escalation) of the study and the dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. Participants in Part 2 (Dose expansion) will receive JNJ-89853413 at the RP2D determined in Part 1.
干预措施: JNJ-89853413 (Drug)
结局指标
主要结局
Number of Participants with Adverse events (AEs) by Severity
时间窗: From screening untill 30 days after last dose of study drug (that is approximately 2.5 years)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
时间窗: 14 days
Participants with dose-limiting toxicity (DLT) will be assessed. DLT is defined as any toxicity that requires discontinuation of treatment, any Grade 5 toxicity; Non-hematologic Toxicity (Grade 3 or 4) and Hematologic Toxicity.
次要结局
- Serum Concentration of JNJ- 89853413(Approximately 2.5 years)
- Area Under the Plasma Concentration-time (AUC[t]) Curve of JNJ-89853413(Approximately 2.5 years)
- Maximum Serum Concentration (Cmax) of JNJ-89853413(Approximately 2.5 years)
- Trough Observed Serum Concentration (Ctrough) of JNJ-89853413(Approximately 2.5 years)
- Number of Participants with Presence of anti-drug Antibodies of JNJ-89853413(Approximately 2.5 years)
- Complete Response (CR) in Acute Myeloid Leukemia (AML)(Approximately 2.5 years)
- Overall Response (OR) in Myelodysplastic Neoplasms (MDS)(Approximately 2.5 years)
- Complete Response in MDS(Approximately 2.5 years)
- Duration of Response (DOR)(Approximately 2.5 years)
- Time to response (TTR)(Approximately 2.5 years)
- Number of Participants Achieving Transfusion independence(Approximately 2.5 years)