A First-in-Human, Multicenter, Open-label, Phase 1 Dose-Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BJ-005 in Patients With Advanced Solid Tumor or Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 85
- 试验地点
- 12
- 主要终点
- To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.
研究概览
简要总结
This is a first-in-human, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BJ-005 in patients with advanced solid tumor or lymphoma. BJ-005 is a recombinant bifunctional molecule, composed of a humanized anti-PD-L1 IgG1 monoclonal antibody (mAb) fused with a portion of the extracellular domain of human TGF-β receptor II (TGF-βRII).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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.
- •Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
- •Histologically or cytologically confirmed advanced solid tumors or lymphoma
- •Measurable or evaluable disease per RECIST v1.1
- •ECOG performance status 0 or 1
- •Life expectancy ≥3 months
- •Adequate hepatic function
- •Calculated creatinine clearance (CrCL) > 50 mL/min (Cockroft-Gault Equation)
- •Adequate Hematological function
- •Prothrombin time, international normalized ratio or activated partial thromboplastin time < 1.5 × ULN
- •Recovery, to Grade 0-1, from adverse events related to prior anticancer therapy
排除标准
- •Prior therapy with anti PD-L1/TGFβRⅡ targeting treatment.
- •Symptomatic primary central nervous system (CNS) tumor of CNS metastases.
- •Uncontrolled hypertension.
- •Significant thrombotic or hemorrhagic events.
- •Prior CAR-T therapy
- •Severe cardiovascular disease.
- •Active infection requiring therapy
- •Active HIV, hepatitis B or hepatitis C virus
- •Active tuberculosis
- •Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to study entry
- •Pregnant or breast-feeding females
- •Active or history of autoimmune disease or inflammatory disorders
结局指标
主要结局
To evaluate the incidence and frequency of adverse events following intravenous (IV) infusion of BJ-005 in patients with advanced solid tumor or lymphoma. The assessment will be conducted per CTCAE 5.0 throughout the conduct of the study.
时间窗: 60 days after the last dose
To determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of BJ-005 following IV infusion in patients with advanced solid tumor or lymphoma.
时间窗: 60 days after the last dose
次要结局
未报告次要终点