CTIS2024-510977-27-00招募中1 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. - D7986C00001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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 1.1., ECOG PS 0 or 1., 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 B/C.
研究者
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