A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 33
- 试验地点
- 13
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
详细描述
This is a Phase II, single arm, open label, multicentre study, assessing the efficacy and safety of AZD0901 in participants with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. The results of the study will provide clinical data on efficacy and safety of an innovation drug in Russian Federation.
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
盲法说明
Open-label
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 adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression.
- •Disease progression on or after at least one prior regimen for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
- •Must have at least one measurable lesion assessed by the Investigator based on RECIST 1.
- •ECOG performance status of 0 or
- •Minimum life expectancy of ≥12 weeks.
- •Adequate organ and bone marrow function.
- •Minimum body weight of 40 kg.
- •Sex and Contraceptive Requirements.
排除标准
- •Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH +.
- •Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
- •CNS metastases or CNS pathology.
- •Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
- •Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy.
- •History of thromboembolic events.
研究组 & 干预措施
AZD0901
Participants will receive AZD0901 IV, Q3W
干预措施: AZD0901 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: At month 6 after date of first dose
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator per RECIST 1.1 to all dosed participants
次要结局
- Progression Free Survival (PFS)(From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months)
- Overall Survival (OS)(From the date of assignment until the date of death from any cause, assessed up to 30 months)
- Disease control rate (DCR) at 12 weeks(At 12 weeks after date of first dose)
- Duration of Response (DoR)(From the date of first documented confirmed response until date of documented progression, assessed up to 30 months)
- Time to Response (TTR)(From the date of first dose to the first documented objective tumor response, assessed up to 30 months)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].(From the time of ICF signature up to 30 months)