A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Type, incidence, severity, seriousness, and relatedness of adverse events
研究概览
简要总结
This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.
详细描述
This study is designed to evaluate the safety, tolerability, and antitumor activity of SGN-CD48A in patients with relapsed or refractory multiple myeloma. This study will be conducted in 2 parts:
- Dose escalation: This part will evaluate increasing doses of SGN-CD48A to identify the maximum tolerated dose.
The first group of patients enrolled on the study will receive the lowest dose of SGN-CD48A. Once this dose is shown to be safe, a second group of patients will be enrolled at the next higher dose. Patients will continue to be enrolled in groups receiving increasing doses until the maximum tolerated dose level is reached. Patients can only be enrolled into a higher dose level once the lower doses have been demonstrated safe. Dose escalation will be conducted using a modified toxicity probability interval (mTPI) study design. 2. Dose expansion: This part will further evaluate the safety, tolerability, and antitumor activity of up to 2 dose levels of SGN-CD48A shown to be safe in the first part of the trial.
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
- •Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group [IMWG])
- •Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
- •Measureable disease, as defined by at least one of the following: serum M protein 0.5 g/dL or higher, urine M protein 200 mg/24 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio
- •Adequate hematologic, renal, and hepatic function
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy greater than 3 months
- •A negative pregnancy test (for females of childbearing potential)
- •Patients must provide written consent
排除标准
- •Pre-existing peripheral neuropathy Grade 2 or higher
- •History of malignancy other than MM within the past 3 years
- •Active cerebral/meningeal disease related to the underlying malignancy
- •Uncontrolled Grade 3 or higher infection
- •Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection
- •Previous allogeneic stem cell transplant
- •History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months
- •Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug
- •Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug.
- •Females who are pregnant or breastfeeding
研究组 & 干预措施
SGN-CD48A
SGN-CD48A
干预措施: SGN-CD48A (Drug)
结局指标
主要结局
Type, incidence, severity, seriousness, and relatedness of adverse events
时间窗: Through 1 month following last dose
Incidence of laboratory abnormalities
时间窗: Through 1 month following last dose
Incidence of dose limiting toxicity
时间窗: Through 3 weeks following first dose
次要结局
- Objective response rate(Through 1 month following last dose)
- Complete response rate(Through 1 month following last dose)
- Duration of objective response(Up to approximately 3 years)
- Duration of complete response(Up to approximately 3 years)
- Progression-free survival(Up to approximately 3 years)
- Overall survival(Up to approximately 3 years)
- Blood concentrations of SGN-CD48A and metabolites(Through 1 month following last dose)
- Incidence of antitherapeutic antibodies(Through 1 month following last dose)