A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 5
- 主要终点
- Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
研究概览
简要总结
This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.
详细描述
ADU-CL-17 is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ADU-1604, an anti-CTLA-4 monoclonal antibody, and explore initial clinical activity in adults with metastatic melanoma. The primary objective of the study is to determine the Recommended Phase 2 Dose (RP2D) of ADU-1604 administered by IV infusion once every 3 weeks for 4 doses.
The study will be conducted in two parts: Dose Escalation followed by Dose Confirmation.
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
- •Male or female aged ≥18 years
- •Histologically-confirmed metastatic or unresectable melanoma
- •Progression of disease following at least one prior therapy, and is not a candidate for, or is intolerant to, established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted). Subjects must have BRAF mutation status confirmed; if a subject is BRAF V600E/K positive, they must have received a BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment
- •Measurable disease according to RECIST (v1.1) [NOT required during Dose Escalation]
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
排除标准
- •Prior diagnosis of uveal or mucosal melanoma
- •Prior treatment with CTLA-4-directed therapy in the metastatic setting. Use of CTLA- 4-directed treatment in the adjuvant or neoadjuvant setting is acceptable provided the last dose was >6 months before the first dose of ADU-1604 and there was no discontinuation of treatment due to a treatment-related toxicity.
研究组 & 干预措施
ADU-1604
ADU-1604 administered as an IV infusion
干预措施: ADU-1604 (Drug)
结局指标
主要结局
Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
时间窗: 9 months
次要结局
未报告次要终点