NCT04443751已完成1 期
A Phase I, Multicenter, Open-label Study of SHR-1702 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
研究概览
简要总结
This study will assess the safety and preliminary efficacy of escalating doses of SHR-1702 monotherapy in relapsed/refractory AML and intermediate-high risk MDS
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
- •Male or female.
- •≥18 years of age.
- •Refractory/Relapsed AML, or failed to achieve complete remission after 2 cycles of induction therapy.
- •Intermediate, High and very high risk MDS according to the revised International Prognostic Scoring System (IPSS-R) who have failed prior therapies, such as azacitidine and decitabine (Scoring≥3.5).
- •Life expectancy≥12 months.
- •With Adequate hematologic and organ function
- •Signed inform consent form
排除标准
- •With a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- •With significant cardiovascular disease.
- •With a history of autoimmune disease.
- •Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
- •Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C.
- •Active or untreated central nervous system (CNS) metastases.
- •Active infection within 2 weeks.
- •Know to be allergic to the ingredients of SHR-1702 injection.
- •Prior allogeneic bone marrow transplantation or solid organ transplant
- •With a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
研究组 & 干预措施
SHR-1702 monotherapy
Experimental
SHR-1702 monotherapy, given intravenously (IV); dose escalation and dose expansion.
干预措施: SHR-1702 (Drug)
结局指标
主要结局
The maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of SHR-1702 monotherapy in patients with AML or MDS.
时间窗: 6 months
次要结局
- Number of participants with the type, frequency, and severity of adverse events (AEs) as a measure of safety and tolerability of SHR-1702 monotherapy in AML and MDS patients(2 years)
- Maximum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS(2 years)
- Immunogenicity as assessed by the presence of anti-drug antibodies(2 years)
- Pharmacodynamic profile as assessed by receptor occupancy(2 years)
- Objective response rate（ORR）for SHR-1702 in AML based on IWG2003 or high risk MDS based on IWG2006(2 years)
- Minimum Concentration (Cmax) of SHR-1702 monotherapy in patients with AML or MDS(2 years)
- Best of Response（BOR）for SHR-1702 in AML or high risk MDS(2 years)
- Progression-Free Survival（PFS) for SHR-1702 in AML or high risk MDS(2 years)
- Overall Survival（OS) for SHR-1702 in AML or high risk MDS(2 years)
研究者
研究点 (1)
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