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

Start Date31 Jul 2012

Sponsor / Collaborator

Sumitomo Pharma America, Inc.

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100 Clinical Results associated with WT-2725

100 Translational Medicine associated with WT-2725

100 Patents (Medical) associated with WT-2725

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Scientific ReportsQ3 · CROSS-FIELD

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

Q3 · CROSS-FIELD

ArticleOA

Author: 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 Deals associated with WT-2725

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 1	-	Sunovion Pharmaceuticals Europe Ltd.	-
Hematologic Neoplasms	Phase 1	-	Sumitomo Pharma Co., Ltd.	-
Hematologic Neoplasms	Phase 1	-	Osaka University	-
Advanced Malignant Solid Neoplasm	Discovery	-	Sumitomo Pharma Co., Ltd.	01 Dec 2013
Neoplasms	Discovery	US	Sumitomo Pharma Co., Ltd.	31 Jul 2012
Hematologic Neoplasms	Discovery	US	-	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01621542 (Pubmed \| Sci Rep)	Phase 1	Advanced cancer	62	WT2725 dosing emulsion	(txlwfgveor) = lgsgahjpad xaslqavznc (jwttdfzeml, 56 - 81) View more	-	16 Nov 2021
NCT01621542 (CTgov)	Phase 1	Neoplasms	64	WT2725 (WT2725 0.3 mg)	kbgxpffqsi(bsfuozjlgu) = qdfozrfamk djtrfnwnei (odmyrqulvg, lvokofgpty - nqpdkgfjgp) View more	-	05 Apr 2019
NCT01621542 (CTgov)	Phase 1	Neoplasms	64	WT2725 (WT2725 0.9 mg)	kbgxpffqsi(bsfuozjlgu) = gfxkqpphxo djtrfnwnei (odmyrqulvg, ixcsvpyhvh - tfkwpesthf) View more	-	05 Apr 2019
NCT01621542 (ASCO2017)	Phase 1	Advanced cancer	62	WT2725 0.3 mg	(ltterguiod) = iwrfiqoimm cpuitapjyy (zfnnmnkqqk ) View more	-	30 May 2017

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