Safety Study of Radiolabeled (111In or 90Y) OTSA101-DTPA, an Anti-Frizzled Homolog 10 (FZD10) Monoclonal Antibody, to Evaluate Safety and Pharmacokinetics in Patients With Relapsed or Refractory Synovial Sarcoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Safety of OTSA101-DTPA-111In
研究概览
简要总结
The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.
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
- •Patients with a documented relapsed or refractory synovial sarcoma after standard chemotherapy
- •Patients ≥18 years of age at the time of obtaining informed consent
- •Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- •Patients with measurable lesion
- •Patients not received any anti-malignancy agent or specified surgical intervention within 28 days or specified radiotherapy within 14 days prior to study registration.
- •Patients without any clinically significant laboratory abnormality.
- •Patients with adequate heart function as measured by echocardiography or multiple gated acquisition scan (MUGA).
- •Patients with adequate pulmonary function as measured by pulmonary function tests.
- •Patients who are either not of childbearing potential or who agree to use a contraception method during the study and for 12 months after the last dose of study drug
- •Patients must be able to understand and be willing to sign a written informed consent
排除标准
- •Patients with documented concurrent malignancy.
- •Patients with brain metastasis with clinical symptoms.
- •Patients with any infection requiring systemic treatment.
- •Patients with lung inflammation or pulmonary fibrosis.
- •Patients with a known history of hypersensitivities to antibody agents or serum albumin agents.
- •Patients with a known history of autoimmune diseases.
- •Patients with myocardial infarction (MI) within 6 months prior to study registration.
- •Patients with uncontrolled diseases.
- •Patients with any disease requiring continuous systemic administration of steroids or immunosuppressants.
- •Patients with evidence of active HBV, HCV or HIV infection.
- •Pregnant or breastfeeding female patients, or female patients with suspected pregnancy.
- •Patients who are participating any other investigational treatments during the study.
- •Patients with psychiatric disorders and is considered to have difficulty to study participation.
研究组 & 干预措施
Single Study Arm, no competitor
干预措施: OTSA101-DTPA-111In (Drug)
Single Study Arm, no competitor
干预措施: OTSA101-DTPA-90Y (Drug)
结局指标
主要结局
Safety of OTSA101-DTPA-111In
时间窗: up to 10 days post dosing
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In
时间窗: up to 72 hours post dosing
Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.
Safety of OTSA101-DTPA-90Y
时间窗: up to 6 weeks post dosing
This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.
次要结局
未报告次要终点