This clinical study is designed to evaluate the safety, immunogenicity and antitumor activity of WT2725. WT2725 will be administered to patients with advanced malignancies known to overexpress WT1

开始日期2012-07-31

申办/合作机构

Sumitomo Pharma America, Inc.

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100 项与 WT-2725 相关的临床结果

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100 项与 WT-2725 相关的转化医学

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100 项与 WT-2725 相关的专利（医药）

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项与 WT-2725 相关的文献（医药）

Scientific Reports3区 · 综合性期刊

A phase I study of the WT2725 dosing emulsion in patients with advanced malignancies

3区 · 综合性期刊

ArticleOA

作者: Zhang, Yi ; Piccioni, David E ; Lukas, Rimas V ; Yamaguchi, Kenichiro ; Fu, Siqing ; Chen, Yu-Luan ; Kesari, Santosh ; Whicher, Kate ; Liu, Hongtao ; Blum, David ; Aregawi, Dawit ; Poola, Nagaraju ; Eddy, John ; Hong, David S

AbstractWT2725 is a Wilms’ tumor gene 1 (WT1)-derived-oligopeptide vaccine designed to induce WT1-specific cytotoxic T-lymphocytes against WT1+ tumors in human leukocyte antigen (HLA)-A*0201+ and/or HLA-A*0206+ patients. Here, we report the results of a phase I study of WT2725. In this phase I, open-label, dose-escalation and expansion two-part study, the WT2725 dosing emulsion was administered as a monotherapy to patients with advanced malignancies known to overexpress WT1, including glioblastoma. In part 1, 44 patients were sequentially allocated to four doses: 0.3 mg (n = 5), 0.9 mg (n = 5), 3 mg (n = 6), and 9 mg (n = 28). In part 2, 18 patients were allocated to two doses: 18 mg (n = 9) and 27 mg (n = 9). No dose-limiting toxicities were observed, so the maximum tolerated dose was not reached. Median progression-free survival was 58 (95% confidence interval [CI] 56–81) days (~ 2 months) across all patients with solid tumors; median overall survival was 394 days (13.0 months) (95% CI 309–648). Overall immune-related response rate in solid tumor patients was 7.5% (95% CI 2.6–19.9); response was most prominent in the glioblastoma subgroup. Overall, 62.3% of patients were considered cytotoxic T-lymphocyte responders; the proportion increased with increasing WT2725 dosing emulsion dose. WT2725 dosing emulsion was well tolerated. Preliminary tumor response and biological marker data suggest that WT2725 dosing emulsion may exert antitumor activity in malignancies known to overexpress the WT1 protein, particularly glioblastoma, and provide a rationale for future clinical development.Trial registration: NCT01621542.

100 项与 WT-2725 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
血液肿瘤	临床1期	-	Sunovion Pharmaceuticals Europe Ltd.	-
血液肿瘤	临床1期	-	Sumitomo Pharma Co., Ltd.	-
血液肿瘤	临床1期	-	Osaka University	-
晚期恶性实体瘤	药物发现	-	Sumitomo Pharma Co., Ltd.	2013-12-01
肿瘤	药物发现	美国	Sumitomo Pharma Co., Ltd.	2012-07-31
血液肿瘤	药物发现	美国	-	-

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01621542 (Pubmed \| Sci Rep)	临床1期	晚期癌症	62	WT2725 dosing emulsion	(淵遞遞繭顧獵蓋築糧鹹) = 衊蓋範鬱餘觸繭膚淵夢鑰蓋壓窪製壓範鹽蓋憲 (糧鏇淵顧簾鏇餘製製鬱, 56 ~ 81) 更多	-	2021-11-16
NCT01621542 (CTgov)	临床1期	肿瘤	64	WT2725 (WT2725 0.3 mg)	憲淵醖網醖選製構繭遞(齋顧築鹹網淵鹽醖鑰艱) = 壓積積獵蓋餘窪醖繭蓋糧選顧淵範鬱壓鑰遞網 (範憲窪願鏇獵觸構淵範, 願願艱襯膚願範築壓壓 ~ 醖願齋艱繭蓋鏇膚鹽膚) 更多	-	2019-04-05
NCT01621542 (CTgov)	临床1期	肿瘤	64	WT2725 (WT2725 0.9 mg)	憲淵醖網醖選製構繭遞(齋顧築鹹網淵鹽醖鑰艱) = 夢鑰糧淵壓網網獵鑰網糧選顧淵範鬱壓鑰遞網 (範憲窪願鏇獵觸構淵範, 糧範積窪醖憲鬱艱蓋衊 ~ 構淵餘鹹廠觸範蓋顧鬱) 更多	-	2019-04-05
NCT01621542 (ASCO2017)	临床1期	晚期癌症	62	WT2725 0.3 mg	(糧鏇鬱淵獵艱獵餘憲積) = 膚淵糧齋網夢襯製網築鏇淵艱構壓顧遞襯鹽窪 (鑰網鬱蓋蓋選窪餘簾齋 ) 更多	-	2017-05-30