Phase 1 Study of SGN-CD352A 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
- 27
- 试验地点
- 11
- 主要终点
- Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
研究概览
简要总结
This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.
详细描述
The study will have 2 parts. In the first part, different doses of SGN-CD352A will be given to different patients (each individual patient will get the same dose for all treatments). The doses will be very low at the start of the trial, and will increase only when the lower dose levels are proven safe.
In the second part of the study, up to 2 dose levels that are both safe and show promising activity against MM will be given to more patients
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] ).
- •Age 18 years or older.
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Life expectancy greater than 3 months.
- •Received at least 2 prior lines of therapy for MM including an immunomodulatory drug and a proteasome inhibitor.
- •Measurable 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 hr or higher, Serum free light chain (SFLC) 10 mg/dL or higher, and Abnormal SFLC ratio.
- •Adequate hematologic, renal, and hepatic function
- •A negative pregnancy test (for females of childbearing potential).
- •Patients must provide written informed consent.
排除标准
- •Other invasive malignancy within the past 3 years.
- •Active cerebral/meningeal disease related to the underlying malignancy.
- •Active Grade 3 or higher infection.
- •Known to be positive for HIV or known to have active hepatitis B or C.
- •Previous allogeneic stem cell transplant.
- •Idiopathic interstitial pneumonia or impaired diffusion capacity of the lung for carbon monoxide (DLCO).
- •Cerebrovascular or cardiovascular event, or congestive heart failure within the last 6 months.
- •Females who are pregnant or breastfeeding.
研究组 & 干预措施
(Dose Escalation) Cohort -1 - 6
SGN-CD352A will be given intravenously (into a vein; IV) every 28 days at increasing doses.
干预措施: SGN-CD352A (Drug)
结局指标
主要结局
Type, incidence, severity, seriousness, and relatedness of adverse events (including laboratory abnormalities)
时间窗: Through 1 month following last dose.
Incidence of dose-limiting toxicity
时间窗: During Cycle 1 (Trial Days 1-28)
次要结局
- Complete response rate(Up to approximately 3 years)
- Incidence of antitherapeutic antibodies (ATA)(Up to approximately 3 years)
- Overall survival(Up to approximately 3 years)
- 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)
- Blood concentrations of SGN-CD352A and metabolites(Up to approximately 3 years)
- Objective response rate(Up to approximately 3 years)