A Phase 1, Open-label, Multicenter, Safety, Pharmacokinetic, Pharmacodynamic Study of ALX148 in Combination With Enfortumab Vedotin and/or Other Anticancer Therapies in Subjects With Urothelial Carcinoma (ASPEN-07)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- First Cycle Dose limiting toxicities (DLTs)
研究概览
简要总结
AT148007 is a Phase 1, open-label, multicenter, safety, pharmacokinetic, pharmacodynamic study of ALX148 in combination with enfortumab vedotin and/or other anticancer therapies in subjects with urothelial carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
- •Must have received prior treatment with an immune checkpoint inhibitor (CPI).
- •Subjects must have received prior treatment with platinum-containing chemotherapy.
- •Subjects must have had progression or recurrence of urothelial cancer.
- •Subjects must have measurable disease according to RECIST (Version 1.1).
- •Adequate bone marrow function.
- •Adequate renal function.
- •Adequate liver function.
- •Adequate Eastern Cooperative Oncology Group (ECOG) performance status.
排除标准
- •Preexisting sensory or motor neuropathy Grade ≥
- •Presence of symptomatic or uncontrolled central nervous system (CNS) metastases.
- •Prior treatment with enfortumab vedotin or other monomethylauristatin (MMAE)-based antibody-drug conjugate (ADCs)
- •Prior treatment with any anti-CD47 or anti-signal regulatory protein-α (SIRPα) agent.
- •Known active keratitis or corneal ulcerations. Subjects with superficial punctate keratitis are allowed if the disorder is being adequately treated.
- •History of uncontrolled diabetes mellitus within 3 months of the first dose of study drug.
研究组 & 干预措施
Evorpacept (ALX148) + Enfortumab Vedotin
Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks.
Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.
干预措施: Evorpacept (Drug)
Evorpacept (ALX148) + Enfortumab Vedotin
Phase 1a Dose Escalation: Evorpacept (ALX148) infusions will be administered every two weeks.
Enfortumab vedotin will be administered at 1.25 mg/kg IV on Days 1, 8, and 15 of each 28-day cycle.
干预措施: Enfortumab Vedotin (Drug)
结局指标
主要结局
First Cycle Dose limiting toxicities (DLTs)
时间窗: Up to 28 days
Adverse Events (AEs) as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0)), timing, seriousness, and relationship to study therapy
时间窗: Up to 24 months
Phase 1: Recommended Phase 2 Dose (RP2D)
时间窗: Up to 15 months
To identify the RP2D of ALX148 in combination with enfortumab vedotin
次要结局
未报告次要终点