A Phase I/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS) Patients After Failure of Hypomethylating Agent (HMA)-Based Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- AEs/SAEs
研究概览
简要总结
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy.
详细描述
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. In Phase I: approximately 15 to 21 subjects and Phase II: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.
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
- •Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- •≥18 years of age, males or females.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •A life expectancy longer than 3 months in the opinion of the investigator at the screening.
- •Male subjects (Including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the ICF.
排除标准
- •History of central nervous system (CNS) involvement.
- •Toxicity from prior antitumor therapy did not return to Grade 1 or baseline (Except for alopecia, neutropenia, anemia, and thrombocytopenia. For neutrophils, hemoglobin, and platelets, please follow Exclusion Criteria No. 5).
- •History of human immunodeficiency virus (HIV) infection.
- •History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.
- •History of allogeneic stem-cell transplantation.
- •Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
- •Pregnant or lactating women.
研究组 & 干预措施
ATG-016
5 mg QD×Days 1-5/week will be the initial dose of this study.
干预措施: ATG-016 (Drug)
结局指标
主要结局
AEs/SAEs
时间窗: 25 months
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
MTD in Phase I
时间窗: 16 months
MTD will be evaluated using the NCI-CTCAE, Version 5.0
ORR in Phase II
时间窗: 25 months
Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
RP2D in Phase I
时间窗: 16 months
RP2D will be determined under the guidance of the SRC.
次要结局
- Disease Control Rate (DCR) in Phase I/II(12 months)
- Duration of Response (DOR) in Phase I/II(12 months)
- Progression-Free Survival (PFS) in Phase I/II(12 months)
- Overall Survival (OS)(12 months)