A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Maximum tolerated dose of ABBV-221
研究概览
简要总结
This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or
- •Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
- •Has an archived, diagnostic tumor tissue available for analysis.
- •Has adequate hematologic, renal, cardiac and hepatic function.
- •Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy.
排除标准
- •Previously received an EGFR-directed monoclonal antibody within the past 4 weeks.
- •Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events.
- •History of major immunologic reaction to any IgG containing agent.
- •Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
研究组 & 干预措施
Arm 1
Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
干预措施: ABBV-221 (Drug)
结局指标
主要结局
Maximum tolerated dose of ABBV-221
时间窗: Up to 2 years from first dose of study drug.
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Area Under the Plasma Concentration-time Curve of ABBV-221
时间窗: Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years).
The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
Number of participants with adverse events
时间窗: Measured for approximately 4 years
Adverse event monitoring will be performed during the study
Maximum Plasma Concentration (Cmax) of ABBV-221
时间窗: Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years).
The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval.
Recommended Phase 2 dose of ABBV-221
时间窗: 1 day of study drug administration within the 21-day cycle at the designated cohort dose
If a maximum tolerated dose (MTD) is reached, the recommended Phase 2 dose (RPTD) of ABBV-221 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
Area Under the Plasma Concentration-time Curve from 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-221
时间窗: Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years).
The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
次要结局
- Assess the effect of systemic ABBV-221 administration on QT prolongation(At Days 1, 2, 3, 5, 8 of Cycle 1; Day 1 of every cycle starting at Cycle 2, and Final Visit (approximately 2 years from first dose of study drug))
- Objective Response Rate (ORR)(At screening; at the end of Cycle 2 and the end of every 3 cycles for approximately 2 years from first dose of study drug)