A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABBV-075 in Subjects With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 10
- 主要终点
- Maximum Tolerated Dose of ABBV-075
研究概览
简要总结
This is a Phase 1, first-in-human, dose escalation study in participants with advanced solid tumors to determine the pharmacokinetics, maximum tolerated dose and the recommended Phase 2 dose of ABBV-075 at different monotherapy dosing schedules. In addition the study will evaluate the safety. tolerability and the pharmacokinetics of ABBV-075 monotherapy or combination therapy in disease specific expansion cohorts.
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
- •Participant in the dose escalation cohorts must have histological confirmation of locally advanced or metastatic solid tumor that is either refractory after standard of care therapy for the disease or for which standard of care therapy or does not exist.
- •Participants in the expansion cohorts must have histological confirmation of AML, Multiple Myeloma, breast cancer, NSCLC, prostate cancer, SCLC, or NHL that is either refractory after standard of care therapy or for which standard of care therapy does not exist.
- •Participant must have an Eastern Cooperative Oncology Group (ECOG) Performance status of: 0 - 1 (dose escalation cohorts) or 0 - 2 (expansion cohorts)
- •Participants in the dose escalation cohort must have a serum albumin of ≥ 3.2 g/dL at screening.
- •Adequate bone marrow, renal, and hepatic function.
- •QTc interval < 480 milliseconds (msec) on the baseline electrocardiogram.
排除标准
- •Participant has untreated brain or meningeal metastases.
- •Participant has received anti-cancer therapy including chemotherapy, immunotherapy, biologic or any investigational therapy within a period of 21 days prior to Study Day
- •Participant has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
- •Symptoms of gross hematuria or gross hemoptysis.
- •Exhibits symptomatic or persistent, uncontrolled hypertension (BP > or = to 140 and/or diastolic pressure of > or = to 90 mm Hg).
- •History of long QT syndrome.
- •Peripheral neuropathy greater than or equal to grade 2.
研究组 & 干预措施
ABBV-075
Dose escalation cohorts of ABBV-075 monotherapy
干预措施: ABBV-075 (Drug)
ABBV-075 and venetoclax combination
Expansion cohorts of ABBV-075 and venetoclax combination therapy
干预措施: ABBV-075 (Drug)
ABBV-075 and venetoclax combination
Expansion cohorts of ABBV-075 and venetoclax combination therapy
干预措施: Venetoclax (Drug)
ABBV-075 expansion
Expansion cohorts of ABBV-075 monotherapy
干预措施: ABBV-075 (Drug)
结局指标
主要结局
Maximum Tolerated Dose of ABBV-075
时间窗: Minimum first cycle of dosing (28 days) up to one year for dose escalation segment.
Maximum tolerated dose is defined as the highest dose level at which less than 2 of 6 participants experience the same dose limiting toxicity. If more than 2 participants experience a different dose limiting toxicity, the maximum tolerated dose may be further evaluated or determined to be exceeded based on discussions with the investigators and medical monitors.
Time to Cmax (peak time, Tmax) for ABBV-075
时间窗: Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Maximum observed plasma concentration (Cmax) of ABBV-075
时间窗: Approximately 24 hours following a single dose of ABBV-075 up to approximately 2 years.
Number of participants with adverse events
时间窗: Screening, Cycle 1 Day 1, 8 and 15, then Day 1 of each cycle up to approximately 2 years.
Area under the curve (AUC)
时间窗: Cycle 1 Day 1 Pre-dose, 1, 2, 3, 4, 6, 8 and 24 hours post ABBV-075 dosing, and on Cycle 1 Day 15 at 14, 17, 20 hours post dose.
Area under the plasma concentration versus time curve from time 0 (pre-dose) to the time of the last measurable concentration (AUC 0-t).
次要结局
- Duration of overall response (DOR)(At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.)
- Objective Response Rate (ORR)(At screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.)
- Progression Free Survival (PFS)(Screening, every 8 weeks from Cycle 1 Day 1, and at the Final visit up to approximately 2 years.)