NCT05113069Enrolling By Invitation1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1912 for Injection as Monotherapy in Patients With B-cell Lymphoma
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Dose Limited Toxicity (DLT)
研究概览
简要总结
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
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
- •Age greater than or equal to18 years old, male or female;
- •Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
- •Life expectancy >12 weeks;
- •Histologically or cytologically confirmed B cell lymphoma;
- •Relapsed and/or refractory disease after at least 1 prior treatment regimen;
- •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 (no need for dose escalation stage).
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
Treatment group
Experimental
SHR-A1912
干预措施: SHR-A1912 (Drug)
结局指标
主要结局
Dose Limited Toxicity (DLT)
时间窗: 21 Days (first cycle)
Recommended phase II dose (RP2D)
时间窗: Up to approximately 2 years
Adverse Events
时间窗: 21 Days after the 1st dosing (first cycle)
Maximum tolerable dose (MTD)
时间窗: 21 Days (first cycle)
次要结局
- Progression-Free Survival (PFS)(Up to approximately 2 years)
- Adverse Events(12 weeks after the last dose)
- Time of maximum observed plasma concentration (Tmax) of SHR-1912(21 days after last dose)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Maximum observed plasma concentration (Cmax) of SHR-1912(21 days after last dose)
- Area under the plasma concentration time curve (AUC) of SHR-1912(21 days after last dose)
- Anti-drug antibody (ADA) of SHR-A1912(12 weeks after last dose)
- Duration of Response (DoR)(Up to approximately 2 years)
- Complete Response Rate (CR)(Up to approximately 2 years)
- Objective Response Rate (ORR)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 3 years)
研究者
研究点 (1)
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