An Open-Label Phase I/II Study of SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Phase I : Adverse events
研究概览
简要总结
This is an open-label, phase I/II dose escalation and expansion trial. The primary objective of dose escalation phase I study is to evaluate the safety and feasibility of SHR1701 in patients with relapsed or refractory classical Hodgkin Lymphoma. The primary objective of open-label, randomized, phase II study is to assess the antitumor effect of SHR1701 alone or in combination with SHR2554 in patients with relapsed or refractory classical Hodgkin Lymphoma.
详细描述
In phase I study, patients received intravenous SHR1701 30-150 mg/kg every 3 weeks. Sequential patient groups received the following doses of SHR1701: 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg, or 150 mg/kg in a 3+3 design with the intention of determining the recommended dose for phase 2. Toxicities are graded according to the Common Terminology Criteria for Adverse Events, version 5.0.
In phase II expansion study, based on the recommended dose of SHR1701 from phase I study, patients are treated with SHR1701 alone if CR rate is satisfactory, or randomized to SHR1701 monotherapy group or SHR2554 plus SHR1701 combination group to assess the clinical efficacy of SHR2554 plus SHR1701 combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
- •12 to 75 years of age.
- •ECOG performance of less than
- •Life expectancy of at least 3 months.
- •Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
- •Subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to Day
- •Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4 weeks.
- •Subjects must have adequate marrow, live, renal and heart functions.
排除标准
- •Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
- •Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
- •Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
- •Prior organ allograft.
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to investigational product administration.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
研究组 & 干预措施
Phase I/ II: SHR1701
Phase I: 30-150 mg/kg, IV over 30 minutes, every 3 weeks. Phase II: recommended dose from phase I trial, IV over 30 minutes, every 3 weeks.
干预措施: SHR-1701 (Drug)
Phase II: SHR2554+ SHR170
SHR2554: 350mg/day, PO, twice a day, every 3 weeks. SHR1701: recommended dose from phase I trial, IV over 30 minutes, every 3 weeks.
干预措施: SHR2554+ SHR1701 (Drug)
结局指标
主要结局
Phase I : Adverse events
时间窗: Up to 90 days after the last dose of study drugs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
Phase I/ II: Complete response rate (CRR)
时间窗: up to 36 months
CRR assess by investigators per the 2014 Lugano classification rate of subjects achieved complete response in all evaluable subjects
次要结局
- Phase II: Progression-free survival (PFS)(up to 36 months)
- Phase II: Overal survival(up to 36 months)
- Phase II: Duration of response (DOR)(up to 36 months)
- Phase II: Objective response rate (ORR)(up to 36 months)
研究者
Han weidong
Professor
Chinese PLA General Hospital