NCT06196203招募中2 期
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes
Akeso15 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2024年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 15
- 主要终点
- Complete remission rate (CRR)
研究概览
简要总结
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years old at the time of enrolment.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Expected life expectancy ≥ 3 months.
- •Newly diagnosed HR-MDS, according to the 2016 World Health Organization (WHO) classification with the presence of < 20% blasts in bone marrow or peripheral blood; Overall IPSS-R score ≥ 3.
- •Ability to undergo the study-required bone marrow sample collection procedures.
- •Suitable venous access for the study-required blood sampling (i.e., including PK and immunogenicity).
- •Female patients of childbearing age must have negative serum pregnancy test results before randomization or per region-specific guidance documented in the informed consent and a negative urine pregnancy test on the day of first dose prior to dosing.
- •Female patients of childbearing potential having sex with an unsterilized male partner must agree to use a highly effective method of contraception from the beginning of screening until 180 days after the last dose of the study treatment.
- •Unsterilized male patients having sex with a female partner of childbearing potential must agree to use an effective method of contraception from the beginning of screening until 180 days after the last dose of study treatment.
排除标准
- •MDS evolving from a pre-existing myeloproliferative neoplasm (MPN), myelodysplastic/myeloproliferative neoplasms (MDS/MPN).
- •Prior treatment with Cluster of Differentiation (CD) 47 or Signal-regulatory protein alpha (SIRPα)-targeting agents.
- •Concurrently participating in another interventional clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- •Patients who previously diagnosed with another malignancy and have any evidence of residual disease.
- •Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies.
- •Patients with any psychiatric or social factor which the investigator deems may interfere with the patient's ability to comply with the requirements of the study.
- •Patients with current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
- •Patients with known cardiopulmonary disease defined as unstable angina, clinically significant arrhythmia, congestive heart failure (New York Heart Association Class III or IV), decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders.
- •Patients who are breastfeeding or plans to breastfeed during the study.
- •Other conditions where the investigator considers the patient inappropriate for enrollment.
研究组 & 干预措施
AK117 (dose 1) in combination with azacitidine
Experimental
Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
干预措施: AK117 (Drug)
AK117 (dose 1) in combination with azacitidine
Experimental
Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
干预措施: Azacitidine (Drug)
AK117 (dose 2) in combination with azacitidine
Experimental
Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
干预措施: AK117 (Drug)
AK117 (dose 2) in combination with azacitidine
Experimental
Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
干预措施: Azacitidine (Drug)
Placebo in combination with azacitidine
Placebo Comparator
Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
干预措施: Placebo (Drug)
Placebo in combination with azacitidine
Placebo Comparator
Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously
干预措施: Azacitidine (Drug)
结局指标
主要结局
Complete remission rate (CRR)
时间窗: Up to approximately 2 years
CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria
次要结局
- Time to response (TTR)(Up to approximately 2 years)
- Duration of CR (DoCR)(Up to approximately 2 years)
- Duration of response (DoR)(Up to approximately 2 years)
- Overall response rate (ORR)(Up to approximately 2 years)
- Event-free survival (EFS)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Time to CR (TTCR)(Up to approximately 2 years)
- Number of subjects with adverse events (AEs)(Up to approximately 2 years)
- Pharmacokinetic characteristics(Up to approximately 2 years)
- Anti-drug antibody (ADA)(Up to approximately 2 years)
研究者
研究点 (15)
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