jRCT2031240647招募中不适用
ONO-7428-01: A phase I, open-label, dose escalation study to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
- •[Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification .
- •Participants who are refractory or intolerant to standard therapy.
- •Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
- •Participants with Eastern Cooperative Oncology Group Performance Status 0 or
- •Participants with tumor tissue samples available for biomarker testing.
排除标准
- •Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
- •Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- •Participants with severe peritoneal dissemination.
- •Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
- •Participants with uncontrolled tumor-related pain.
- •Participants with active or history of interstitial lung disease or pulmonary fibrosis.
结局指标
主要结局
-
Tolerability, safety
次要结局
未报告次要终点
研究者
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