CTIS2023-507995-33-00进行中（未招募）1 期
Open label, non-randomized, Phase 1b/2 trial investigating the safety, tolerability, and antitumor activity of S095029 (anti-NKG2A antibody) as a part of combination therapy in participants with locally advanced and unresectable or metastatic MSI-H/dMMR gastro-esophageal junction/gastric cancer - CL1-95029-002
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 57
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
- •Participants must have a histologically or cytologically confirmed diagnosis of a locally advanced and unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma., Participants’ tumor must have an MSI-H or dMMR status according to institutional guidelines and/or according to the College of American Pathologists, determined at any time prior to enrolment. This status may be documented in a report in the participant’s medical history or the MSI-H/dMMR status may be documented by testing archival tumor tissue or tissue from a newly collected tumor biopsy (if no appropriate archived specimen is available).
排除标准
- •Has received prior therapy with any checkpoint inhibitor (anti-PD-1, anti-programmed cell death ligand 1 (PDL1), anti-CTLA4)., Has received more than one previous line of treatment in the locally advanced and unresectable or metastatic setting. Previous treatment line may include trastuzumab and chemotherapy, or doublet/triplet chemotherapy regimens. Note: participants who have received only one cycle of chemotherapy prior to determination of their tumor’s MSI-H status, and who have not yet been treated with an anti-PD-1/L1 agent are not considered to have had one prior line of treatment. Previous treatment with chemotherapy in the neoadjuvant or adjuvant setting is permitted and is not counted as a previous line of therapy for the purpose of determining a patient’s eligibility., Participants who have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (shorter interval, at least 5 half-lives, for kinase inhibitors or other short half-life drugs), prior to first study treatment., Prior radiotherapy if completed less than 2 weeks before first study treatment or have had a history of radiation pneumonitis. Participants who have not recovered from all radiation-related toxicities and require corticosteroids. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-central nervous system (CNS) disease., Major surgery less than 4 weeks prior to the first study treatment or participants who have not recovered from the side effects of the surgery.
研究者
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