A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-085, an Antibody Drug Conjugate, in 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
- 85
- 试验地点
- 20
- 主要终点
- Maximum observed plasma concentration (Cmax) of ABBV-085.
研究概览
简要总结
This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.
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
- •Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens:
- •Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens >=2 x upper limit of normal (ULN).
- •All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
- •Participant has adequate bone marrow, renal, hepatic and cardiac function.
- •Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.
排除标准
- •Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-
- •Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of ABBV-
- •Unresolved adverse events >= Grade 2 from prior anticancer therapy, except for alopecia.
- •Participant has ongoing hemolysis.
- •Major surgery within <=28 days prior to the first dose of ABBV-
- •Clinically significant uncontrolled condition(s).
- •Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.
研究组 & 干预措施
Arm A4 (ABBV-085)
ABBV-085 administered on at 28 day cycle and enrolling at MD Anderson
干预措施: ABBV-085 (Drug)
Arm A3 (ABBV-085)
ABBV-085 will be administered at every cycle (28-day cycles).
干预措施: ABBV-085 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of ABBV-085.
时间窗: Up to 24 months
Area under the curve (AUC) from time zero to the last measurable concentration AUC(0-t) of ABBV-085.
时间窗: Up 24 months
AUC (0-t) = Area under the serum concentration curve from time zero (pre-dose) to the time of the last measurable concentration.
Number of participants with Adverse Events
时间窗: Up to 24 months
Collect all adverse events at each visit.
Terminal elimination half life of ABBV-085.
时间窗: UP to 24 months
次要结局
- Objective response rate (ORR)(Up to 24 months)
- Progression free survival (PFS)(Up to 24 months)
- Duration of overall response (DOR)(Up to 24 months)