2024-510977-27-00招募中2 期
A Master Protocol of an Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Novel Combinations in Participants with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- ORR in response evaluable set
研究概览
简要总结
To assess the efficacy of novel agent plus chemotherapy by evaluation of ORR (objective response rate) and PFS6 (proportion of participants alive and progression-free at 6 months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Substudy 6
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •18 years or older at the time of signing the ICF.
- •Body weight > 35 kg.
- •Previously untreated for unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
- •Has measurable target disease assessed by the Investigator based on RECIST 1.
- •ECOG PS 0 or
- •Life expectancy of at least 12 weeks.
- •Adequate organ and bone marrow function.
排除标准
- •Participants with HER2-positive (3+ by IHC, or 2+ by IHC and positive by ISH) or indeterminate gastric or GEJ carcinoma.
- •Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression.
- •Participants with ascites which cannot be controlled with appropriate interventions.
- •Uncontrolled intercurrent illness.
- •Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment.
- •History of another primary malignancy.
- •Previous treatment with an immune-oncology agent.
- •Active infectious diseases, including tuberculosis, HIV infection, or hepatitis A/B/C.
研究组 & 干预措施
volrustomig
Experimental
Participants receiving volrustomig
干预措施: volrustomig (Drug)
结局指标
主要结局
ORR in response evaluable set
ORR in response evaluable set
PFS6 in full analysis set
PFS6 in full analysis set
次要结局
- DoR per RECIST 1.1 based on Investigator assessment.
- PFS per RECIST 1.1 as assessed by the Investigator.
- OS.
- Incidence of AEs, AESIs, and SAEs; physical examination; Laboratory findings; vital signs; 12-lead ECG.
- Incidences of ADAs against novel agent in serum.
- Serum concentrations of novel agent and derived PK parameters.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (6)
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