A Phase 1b/2 Open-label Study to Evaluate the Safety/Efficacy of MEDI-551 in Combination With Immunomodulating Therapy in Subjects With Relapsed or Refractory Aggressive B-cell Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities
研究概览
简要总结
This is a Phase 1b/2 open-label study to evaluate the safety/efficacy of MEDI-551 + MEDI0680 in participants with relapsed or refractory aggressive B-cell lymphomas who have failed 1-2 prior lines of therapy.
详细描述
This is a Phase 1b/2, multicenter, open-label, study of MEDI-551 in combination with immunomodulating therapy evaluating the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity in subjects with relapsed or refractory aggressive B-cell lymphomas
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
Participants will receive IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
干预措施: MEDI-551 12 mg/kg (Drug)
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
干预措施: MEDI-551 12 mg/kg (Drug)
MEDI-551 12 mg/kg and MEDI0680 2.5 mg/kg
Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
干预措施: MEDI0680 2.5 mg/kg (Drug)
MEDI-551 12 mg/kg and MEDI0680 10 mg/kg
Participants will receive IV infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13 (each cycle of 28 days) and IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
干预措施: MEDI0680 10 mg/kg (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Vital Signs, Physical Findings Abnormalities
时间窗: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
Vital signs included parameters such as blood pressure, temperature, respiratory rate, and pulse oximetry. An abnormal vital signs and physical findings that was judged by the investigator to be medically significant was reported an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the end of study treatment.
Number of Participants With Best Overall Response
时间窗: Day 1 to Day 28 of Cycle 13 (28-day cycle)
The best overall response was calculated, based upon the disease assessments recorded during the study visits, and summarized with the number of participants for the following categories: complete response (disappearance of all evidence of disease), partial response (regression of measurable disease and no new sites), stable disease (SD), progessive disease (PD), and non- evaluable (NE).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
An Adverse Event (AE) is any unfavourable and unintended signs, symptoms, or diseases temporally associated with use of study drug, whether or not considered related to study drug. SAE is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life-threatening, a congenital anomaly/birth defect, or an important medical event. TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 90 days after the end of treatment (EOT).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Clinical Laboratory Abnormalities
时间窗: From treatment administration to 90-days after last dose of study drug (up to approximately 2 years)
An abnormal laboratory findings that was judged by the investigator to be medically significant was reported as an AE. TEAEs were defined as events present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, for the period extending to 90 days after the end of study drug.
Maximum Tolerated Dose (MTD) of MEDI-551
时间窗: Day 1 to Day 28 of Cycle 1 (28-day cycle)
The Maximum Tolerated Dose, defined as the highest dose where less than or equal to (\<= 1) out of 6 subjects experiences a dose limiting toxicity (DLT) during the DLT evaluation period (Day 1 to Day 28 of Cycle 1) or the highest protocol specified dose not exceeding MTD.
次要结局
- Mean Peak and Trough Concentrations of MEDI551(End of Infusion (EOI) of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1)
- Mean Peak and Trough Concentrations of MEDI0680(EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1)
- Duration of Complete Response(From treatment administration to 90-days after last dose of study drug (up to approximately 2 years))
- Number of Participants With Disease Control(From treatment administration to 90-days after last dose of study drug (up to approximately 2 years))
- Terminal Half-Life (t1/2) of MEDI551(EOI of Cycle 1 Day 1; Pre-dose and EOI of C1D8, C2D1, C3D1 and C4D1)
- Duration of Disease Control(From treatment administration to 90-days after last dose of study drug (up to approximately 2 years))
- Terminal Half-Life (t1/2) of MEDI0680(EOI of Cycle 1 Day 2; Pre-dose and EOI of C1D15, C2D1, C3D1 and C4D1)
- Time to Response (TTR)(From treatment administration to 90-days after last dose of study drug (up to approximately 2 years))
- Overall Survival (OS)(From treatment administration to 90-days after last dose of study drug (up to approximately 2 years))
- Number of Participants With Positive Anti-Drug Antibodies (ADA) for MEDI-551 and MEDI0680(30 min prior to infusion of MEDI-551 on Day 1 of Cycles 1, 2, 6, 9, and 12 and up to 90-days after last dose of study drug (up to approximately 2 years))
- Progression-free Survival (PFS)(From treatment administration to 90-days after last dose of study drug (up to approximately 2 years))