NCT07153965尚未招募2 期
An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2025年9月1日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
研究概览
简要总结
This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.
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
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
sac-TMT plus Tagitanlimab
Experimental
干预措施: Sacituzumab Tirumotecan plus Tagitanlimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
时间窗: up to approximately 60 months
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
次要结局
- Progression Free Survival (PFS) as Assessed by Investigator per RECIST Version 1.1(up to approximately 60 months)
- Overall Survival (OS)(up to approximately 60 months)
- Disease control response (DCR) as Assessed by Investigator per RECIST Version 1.1(up to approximately 60 months)
- Safety and Tolerability(up to approximately 60 months)
- Duration of response (DoR)(up to approximately 60 months)
- Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(up to approximately 60 months)
- Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 (EORTC QLQ-BR23)(up to approximately 60 months)
研究者
研究点 (1)
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