A Phase 1 Dose-escalation Study of Radio- Labeled Antibody, FF-21101(90Y) for the Treatment of Advanced Cancer

Fujifilm Pharmaceuticals U.S.A., Inc.4 个研究点分布在 1 个国家目标入组 73 人开始时间: 2016年1月最近更新: 2025年4月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Fujifilm Pharmaceuticals U.S.A., Inc.
入组人数: 73
试验地点: 4
主要终点: Safety and tolerability of radio-labeled FF21101

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.

详细描述

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors. This is an open label study that will recruit approx 70 patients

研究设计

研究类型: Interventional
分配方式: Non Randomized
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

•Males and females ≥ 18 years of age
•Histologically or cytologically confirmed advanced solid tumor malignancy, refractory or relapsed from prior therapy, or for whom no alternative therapy is available
•At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
•Archival tumor sample available, or be willing to undergo a fresh tumor biopsy, prior to study
•At least one measurable disease site that meets target lesion requirements
•Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
•Life expectancy of ≥ 3 months
•Adequate hematologic parameters without ongoing transfusional support:
•Negative serum pregnancy test
•Ability to provide written informed consent

排除标准

•Previous radioimmunotherapy. Previous antibody-based therapy is allowed as long as ≥ 28 days has elapsed from last dose to study treatment.
•Prior radiation to > 30% of the red marrow or to maximal tolerable level for any organ
•Serious cardiac condition within the last 6 months
•Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of antimicrobials that are considered to be essential for care of the patient
•History of retinal degenerative disease, history of uveitis, history of retinal vein occlusion (RVO), or any eye condition that would be considered a risk factor for RVO or has medically relevant abnormalities identified on screening ophthalmologic examination
•Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior, or currently treated brain metastases are allowed.
•Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
•Known autoimmune disease
•Active infection requiring intravenous (IV) antibiotic usage within the last week prior to the dosimetry portion of the study
•Corticosteroid use within 2 weeks of study treatment
•Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or confound the interpretation of study results
•Pregnant or breast-feeding