A Phase 1 Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Part 1: Incidence of dose limiting toxicities
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with chronic phase chronic myeloid leukemia with and without T315I mutations in patients who has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
详细描述
This first-in-human trial with ELVN-001 is a dose escalation study with the primary purpose to identify the recommended dose(s) for expansion (RDEs) of single agent ELVN-001 in chronic phase CML with or without T315I mutations. The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development of ELVN-001 in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who have failed, or are intolerant to, or not a candidate for, at least 2 prior TKIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •BCR::ABL1 positive CP-CML that has failed, or the patient is intolerant to, or not a candidate for, at least 2 prior TKIs.
- •ECOG performance status of 0 to
- •The patient was born in Japan and both parents and grandparents are Japanese.
- •Adequate hematologic, hepatic and renal function.
- •Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001.
排除标准
- •Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
- •History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause.
- •QTc >470 ms.
研究组 & 干预措施
Part 1 Dose Escalation
ELVN-001 administered in 3+3 dose escalation
干预措施: ELVN-001 (Drug)
Part 2 Dose Exploration
ELVN-001 administered to approximately 6 participants per dose level who may be enrolled at or below the dose levels that have been deemed safe and tolerable in Part 1
干预措施: ELVN-001 (Drug)
结局指标
主要结局
Part 1: Incidence of dose limiting toxicities
时间窗: 28 days
DLTs will be used to support that the recommended doses for expansion are \</= MTD
Part 1: Incidence of adverse events (AEs)
时间窗: Up to 28 days
Adverse events will be used to support that the recommended doses for expansion are likely to be tolerable
Part 1: Incidence of clinically significant laboratory abnormalities
时间窗: Up to 28 days
Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Part 1: Incidence of clinically significant ECG abnormalities
时间窗: Up to 28 days
Clinically significant ECG abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
Part 2: Incidence of adverse events
时间窗: Up to 3 years
Adverse events will be used to support that the dose(s) evaluated in exploration is tolerable
Part 2: Incidence of clinically significant laboratory abnormalities
时间窗: Up to 3 years
Clinically significant ECG abnormalities will be used to support that the dose(s) evaluated in exploration is tolerable
Part 2: Incidence of clinically significant ECG abnormalities
时间窗: Up to 3 years
Clinically significant ECG abnormalities will be used to support that the recommended dose(s) evaluated in exploration is tolerable
次要结局
- Time of maximum concentration(6 months)
- Minimum concentration(6 months)
- Area under the curve(6 months)
- Maximum concentration(6 months)
- Molecular response (MR)(Up to 3 years)
- Duration of Molecular Response(Up to 3 years)
- Complete Hematologic Response (CHR)(Up to 3 years)