NCT06104553招募中1 期
A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma
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
- 132
- 试验地点
- 1
- 主要终点
- Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy
研究概览
简要总结
This study aims to evaluate the safety, PK and preliminary anti-tumour activity of SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age greater than or equal to18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- •Life expectancy >3 months;
- •Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
- •Previous systematic anti-tumor therapy should meet the following requirements: 1) Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort).
- •At least one measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as > 1.0 cm in its longest diameter.
排除标准
- •Received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received Car-T cell therapy within 12 weeks before the first study treatment;
- •History of recent major surgery or severe trauma within 4 weeks before the first study treatment;
- •Received anti-tumour treatment within 2 weeks before the first study treatment;
- •Central nervous system (CNS) infiltration;
- •Active infection with HBV or HCV;
- •History of immunodeficiency, including HIV serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis;
- •Active infection or unexplained fever>38.5℃;
- •History of severe cardiovascular disease.
研究组 & 干预措施
SHR-A1912 combined with R-Chemo (Phase 1b)
Experimental
干预措施: SHR-A1912; R-Chemo (Drug)
SHR-A1912 combined with R-Chemo (Phase 2)
Experimental
干预措施: SHR-A1912; R-Chemo (Drug)
结局指标
主要结局
Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy
时间窗: The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
Phase 1b: Incidence and severity of AE
时间窗: Up to follow-up period, approximately 24 months]
Phase 2: Objective response rate
时间窗: assessed up to approximately 24 months
次要结局
- Phase 2: Complete response rate (CRR)(assessed up to approximately 24 months)
- Phase 1b: Objective response rate(assessed up to approximately 24 months)
- Phase 1b: Complete response rate (CRR)(assessed up to approximately 24 months)
- Phase 1b: Duration of remission (DoR)(assessed up to approximately 24 months)
- Phase 1b: Progression-free survival (PFS)(assessed up to approximately 24 months)
- Phase 2: Duration of remission (DoR)(assessed up to approximately 24 months)
- Phase 2: Concentration of free toxin(Up to follow-up period, approximately 24 months)
- Phase 1b: Toxin binding antibody to SHR-A1912(Up to follow-up period, approximately 24 months)
- Phase 1b: Total antibody to SHR-A1912(Up to follow-up period, approximately 24 months)
- Phase 1b: Concentration of free toxin(Up to follow-up period, approximately 24 months)
- Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912(Up to follow-up period, approximately 24 months)
- Phase 2: Total antibody to SHR-A1912(Up to follow-up period, approximately 24 months)
- Phase 2: Incidence and severity of AE(Up to follow-up period, approximately 24 months)
- Phase 2: Progression-free survival (PFS)(assessed up to approximately 24 months)
- Phase 2: Toxin binding antibody to SHR-A1912(Up to follow-up period, approximately 24 months)
- Phase 2: Anti-drug antibodies (ADA) to SHR-A1912(Up to follow-up period, approximately 24 months)
研究者
研究点 (1)
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