NCT06656494招募中1 期
A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.
适应症
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
- 266
- 试验地点
- 28
- 主要终点
- MDS cohort：mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point during the study per revised IWG 2006 MDS Criteria.
研究概览
简要总结
Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.
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
- •Eligible subjects must meet all of the following criteria:
- •Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia [APL]) or MDS per 2016 World Health Organization (WHO) criteria.
- •For AML (except for APL) cohort:
- •Previously treated relapsed/refractory AML subjects
- •Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and <60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy
- •For MDS cohort: Adult TN MDS and R/R MDS: revised International Prognostic Scoring System (IPSS-R) score > 3 and bone marrow blasts ≥ 5%.
- •Subject must have a projected life expectancy of at least 12 weeks.
- •Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.
- •Subject must have adequate liver function
排除标准
- •R/R AML or R/R MDS with no response or intolerance to post azacitidine or BCL-2i.
- •Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .
- •Subject has known central nervous system (CNS) leukemia.
- •Suggest patients with active hepatitis B or C virus infection
- •History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
- •Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.
研究组 & 干预措施
ICP-248 in combination with azacitidine
Experimental
干预措施: ICP-248 (Drug)
ICP-248 in combination with azacitidine
Experimental
干预措施: Azacitidine (Drug)
结局指标
主要结局
MDS cohort：mOR rate, including CR, mCR, and PR, assessed by Investigator at any time point during the study per revised IWG 2006 MDS Criteria.
时间窗: 2.5 years
Incidence, type, and severity of dose-limiting toxicity (DLT).
时间窗: 2.5 years
Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).
时间窗: 2.5 years
The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.
时间窗: 2.5 years
AML cohort:Composite complete remission rate by Investigator per ELN 2017 criteria.
时间窗: 2.5 years
AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.
时间窗: 2.5 years
Incidence, type, and severity of dose-limiting toxicity (DLT).
时间窗: 2.5 years
Recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD).
时间窗: 2.5 years
The incidence, nature, and severity of adverse events (AEs) as assessed per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) criteria.
时间窗: 2.5 years
次要结局
- Area under the curve (AUC) of ICP-248.(2.5 years)
- Trough concentration(Ctrough) of ICP-248.(2.5 years)
- AML cohort：Partial Response (PR) by investigator per ELN 2017 criteria.(2.5 years)
- AML cohort：Morphologic leukemia-free state (MLFS) by investigator per ELN 2017 criteria.(2.5 years)
- AML cohort：Composite complete remission rate: The proportion of subjects with complete remission (CR) and CR with incomplete hematologic recovery (CRi) by Investigator per European Leukemia Net (ELN) 2017 criteria.(2.5 years)
- AML cohort：Composite complete remission rate by completion of cycle 2 by Investigator per ELN 2017 criteria.(2.5 years)
- AML cohort：Overall survival (OS) by investigator per ELN 2017 criteria.(2.5 years)
- Maximum concentration (Cmax)of ICP-248.(2.5 years)
- The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.(2.5 years)
- Time of maximum observed plasma(Tmax)of ICP-248.(2.5 years)
- Apparent clearance (CL/F) of ICP-248.(2.5 years)
- AML cohort：Duration of Response (DOR) by investigator per ELN 2017 criteria.(2.5 years)
- AML cohort：Relapse-free Survival (RFS) by investigator per ELN 2017 criteria.(2.5 years)
- AML cohort：Event-free Survival (EFS) by investigator per ELN 2017 criteria.(2.5 years)
- MDS cohort：Modified overall response (mOR) rate, including CR, marrow complete response (mCR), and PR, assessed by Investigator at any time point during the study per revised International Working Group (IWG) 2006 MDS Criteria(2.5 years)
- MDS cohort：Complete remission(CR) rate by Investigator per revised IWG 2006 MDS Criteria(2.5 years)
- MDS cohort：Event-free survival (EFS) by Investigator per revised IWG 2006 MDS Criteria(2.5 years)
- MDS cohort：Duration of modified overall response (DmOR) by Investigator per revised IWG 2006 MDS Criteria(2.5 years)
- MDS cohort：Overall survival(OS) by Investigator per revised IWG 2006 MDS Criteria(2.5 years)
- MDS cohort：Marrow complete response (mCR) rate by Investigator per revised IWG 2006 MDS Criteria(2.5 years)
- The incidence, nature, and severity of adverse events (AEs) as assessed per NCI-CTCAE v5.0 criteria.(2.5 years)
- Area under the curve (AUC) of ICP-248.(2.5 years)
- Time of maximum observed plasma(Tmax)of ICP-248.(2.5 years)
- Apparent clearance (CL/F) of ICP-248.(2.5 years)
研究者
研究点 (28)
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