Phase II Trial of Bintrafusp Alfa in Subjects with Thymoma and Thymic Carcinoma

Bintrafusp Alfa 在胸腺瘤和胸腺癌受试者中的 II 期试验

• 批准号: 10926444
• 负责人: Arun Rajan
• 金额: $ 26.53万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10926444
• 关键词: Adverse event; Aftercare; Biopsy; Cells; Chimeric Proteins; Data; Disease; Enrollment; Epithelium; Evaluation; Immune; Patients; Progression-Free Survivals; Recurrence; Refractory; Relapse; Safety; Thymic Carcinoma; Thymoma; Thymus Epithelial Neoplasm; Thymus Gland; Transforming Growth Factor beta; Transforming Growth Factors; cohort; objective response rate; partial response; participant enrollment; phase 2 study; phase II trial; programmed cell death ligand 1; response

Bintrafusp alfa, a bifunctional fusion protein that targets PD-L1 and transforming growth factor-b (TGF-b). Retrospective analysis of biopsies obtained from 20 patients with stage IV thymic carcinoma and 13 cases of stage III/IV thymoma, showed TGF-b expression in 65% cases of thymic carcinoma and 15% cases of thymoma with a lower median survival among patients with thymic carcinoma (30 months versus 63 months). Based on these data, we developed a phase II study of bintrafusp alfa for patients with recurrent thymic epithelial tumors. Four patients have been enrolled and treated to date (1 thymoma, 3 thymic carcinoma). One partial response and one case of durable disease stabilization have been observed. Treatment is well tolerated with manageable adverse events. In the first stage of the trial 7 patients will be enrolled in each cohort. If 2 or more responses are observed in each cohort, the study will proceed to stage 2. However, accrual will be stopped if less than 2 responses are noted in each cohort among the first 7 patients enrolled.

Bintrafusp Alfa，一种靶向PD-L1并转化生长因子B（TGF-B）的双功能融合蛋白。回顾性分析了从20例IV期胸腺癌和13例III/IV期胸腺瘤患者获得的活检，在胸腺癌的65％病例中表现出TGF-B表达，胸腺瘤和15％的胸腺瘤患者的胸腺瘤生存率较低的胸腺瘤患者（30个月对63个月，患有胸腺癌的中位数较低）。基于这些数据，我们针对复发性胸腺上皮肿瘤的患者开发了对Bintrafusp alfa的II期研究。迄今为止，已经入学并接受了四名患者（1例胸腺瘤，3个胸腺癌）。已经观察到一种部分反应和一例持久的疾病稳定。可控制的不良事件可以很好地耐受治疗。在试验的第一阶段，每个队列将招募7例患者。如果在每个队列中观察到2个或更多的反应，则该研究将继续进行第2阶段。但是，如果在招募的前7名患者中，每个队列中都记录了少于2个反应，则应计入。