A First-In-Human Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA 3501 in Patients With Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma and Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 51
- 试验地点
- 3
- 主要终点
- Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1
研究概览
简要总结
The goal of this clinical trial is to determine the MTD or OBED of DA-3501 given in Q3W to determine a wRP2D in patients with advanced CLDN18.2 expressing (CLDN18.2+) GC/GEJ and advanced CLDN18.2+ PDAC.
Participants will receive the assigned dose once every three weeks and, according to the study procedures, will undergo tumor assessments as well as safety assessments, PK evaluations, and ADA testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 19 years
- •Histologically or cytologically documented advanced CLDN18.2+ GC/GEJ adenocarcinoma or advanced CLDN18.2+ PDAC
- •Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- •Life expectancy ≥12 weeks as judged by the Investigator
排除标准
- •Cardiac abnormalities
- •Gastrointestinal abnormalities
- •Active and clinically significant bacterial, fungal, or viral infection, including known hepatitis B virus (HBV), known hepatitis C virus (HCV), known human immunodeficiency virus (HIV).
- •Active systemic infection requiring IV antibiotics therapy.
研究组 & 干预措施
Dose Level 5
干预措施: DA-3501 (Drug)
Dose Level 6
干预措施: DA-3501 (Drug)
Dose Level 7
干预措施: DA-3501 (Drug)
Dose Level 8
干预措施: DA-3501 (Drug)
Dose Level 1
Participants will receive DA-3501 at dose level 1 administered intravenously once every three weeks.
干预措施: DA-3501 (Drug)
Dose Level 2
干预措施: DA-3501 (Drug)
Dose Level 3
干预措施: DA-3501 (Drug)
Dose Level 4
干预措施: DA-3501 (Drug)
Dose Level 9
干预措施: DA-3501 (Drug)
Dose Level 10
干预措施: DA-3501 (Drug)
Dose Level 11
干预措施: DA-3501 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) based on Dose-Limiting Toxicities (DLTs) during Cycle 1
时间窗: 21 days
Optimal Biological Effective Dose (OBED) Based on best Overall Response Rate (ORR)
时间窗: 42 days
次要结局
未报告次要终点