A Phase I, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of Anti-BAFFR mAb(Monoclonal Antibody), ESG206 in Subjects With B-cell Lymphoid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percentage of Participants Experiencing Any Treatment Emergent Adverse Events
研究概览
简要总结
This is a phase I, multicenter, open label, sequential-cohort, dose escalation study of ESG206. The purpose is to evaluate the clinical safety, tolerability, PK (pharmacokinetics), and preliminary efficacy and to establish the MTD (maximum tolerated dose), if any, and RP2D (recommended phaseII dose) of ESG206 in adult subjects with B lymphoid malignancies.
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
- •Willing and able to provide written informed consent for the trial.
- •Male or female and at least 18 years of age.
- •Subjects must have a histologically confirmed (or documented), incurable B-cell hematologic malignancy that had progressed despite standard of care therapy and for which there was no alternative therapy of proven benefit or no effective standard therapy is available or tolerable.
- •Measurable or evaluable Disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Subject must have adequate organ function.
排除标准
- •Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days before first dosing.
- •Had major surgery within 4 weeks before first dosing.
- •Had undergone an autologous stem cell transplant within 100 days before first dosing.
- •Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, or renal disease).
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.
- •Pregnant or breastfeeding women.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
研究组 & 干预措施
ESG206 dose level 1
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
干预措施: ESG206 (Drug)
ESG206 dose level 2
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
干预措施: ESG206 (Drug)
ESG206 dose level 3
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
干预措施: ESG206 (Drug)
ESG206 dose level 4
ESG206 will be administered intravenously at dose level 1 every two weeks in a 28-day cycle
干预措施: ESG206 (Drug)
结局指标
主要结局
Percentage of Participants Experiencing Any Treatment Emergent Adverse Events
时间窗: First dose date up to last dose plus 30 days
Treatment-emergent adverse events (TEAEs) were defined as: Any adverse event (AE) that happens after treatment initiation, or AE that was present at time of treatment initiation but worsened after treatment initiation, or AE that was present and resolved prior to treatment and reappeared after treatment initiation after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events.
次要结局
- Cmax(Up to 20 months)
- AUC0-inf(Up to 20 months)
- Tmax(Up to 20 months)
- T1/2(Up to 20 months)
- Overall Response Rate (ORR)(Up to 20 months)
- Progression-free Survival (PFS)(Up to 20 months)
- ADA(Up to 20 months)