A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
研究概览
简要总结
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant with histologically confirmed advanced solid tumor.
- •Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
- •Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Participant must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue available for analysis.
- •Participant has adequate bone marrow, renal, and hepatic function.
排除标准
- •Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABBV-
- •Participant has known uncontrolled metastases to the central nervous system. Participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of ABBV-
- •Participant has unresolved clinically significant adverse events >= Grade 2 from prior anticancer therapy except for alopecia or anemia.
- •Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
研究组 & 干预措施
ABBV-399
ABBV-399 via intravenous administration at escalating dose levels.
干预措施: ABBV-399 (Drug)
结局指标
主要结局
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
时间窗: Up to 24 months
AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399
时间窗: Up to 21 days
MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Terminal elimination half life (t1/2)
时间窗: Up to 24 months
Terminal elimination half life (t1/2)
Time to Cmax (Tmax)
时间窗: Up to 24 months
Time to Cmax (Tmax)
Maximum Observed Concentration (Cmax)
时间窗: Up to 24 months
Maximum observed concentration (Cmax)
次要结局
- Duration of response (DOR)(Up to 24 months)
- Progression-Free Survival (PFS) Time(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)