Tucotuzumab celmoleukin(Tucotuzumab celmoleukin) - 药物靶点：EpCAM x IL-2R_专利_临床

概要

基本信息

药物类型

抗体

别名

KS-interleukin-2、Tucotuzumab celmoleukin (USAN/INN)

+ [2]

靶点

EpCAM x IL-2R

作用机制

EpCAM抑制剂(上皮细胞粘附分子抑制剂)、IL-2R激动剂(白细胞介素-2受体复合体激动剂)

治疗领域

肿瘤内分泌与代谢疾病呼吸系统疾病+ [2]

在研适应症-

非在研适应症

膀胱癌结直肠癌肾肿瘤+ [6]

原研机构

EMD Lexigen Research Center Corp.

在研机构-

非在研机构

EMD Serono, Inc.EMD Lexigen Research Center Corp.Merck KGaA

+ [1]

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

序列信息

Sequence Code 1191632848H

来源: *****

Sequence Code 88455L

来源: *****

关联

5

项与 Tucotuzumab celmoleukin 相关的临床试验

EUCTR2006-004566-13-ES / Not yet recruitingN/A

An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.Estudio en fase abierta, aleatorizado, de fase II en sujetos con enfermedad avanzada, en cáncer de pulmón microcítico (CPM), después de una respuesta inicial (respuesta completa o parcial) a una terapia basada en platino, para evaluar el efecto de EMD 273066 tras dosis bajas de ciclofosfamida sobre la progresión de la enfermedad y la supervivencia frente a la mejor terapia de soporte.

开始日期2008-05-19

申办/合作机构

Merck KGaA

EUCTR2006-004566-13-DE / Not yet recruitingN/A

An open-label, randomised, phase II study in subjects with extensive disease, small cell lung cancer (ED-SCLC) after an initial response (complete response or partial response) to platinum-based therapy to determine the effect of EMD 273066 following low-dose cyclophosphamide on disease progression and survival versus best supportive care alone.

开始日期2008-03-26

申办/合作机构

Merck KGaA

NCT00408967 / Withdrawn临床2期

An Open-label Phase II Study of Two Dose Levels of EMD 273066 Administered With Low-dose Cyclophosphamide Following Objective Response to Second-line Chemotherapy in Women With Recurrent Ovarian Carcinoma

The purpose of this study is to determine if either of two doses of EMD 273066 when given with a low dose of cyclophosphamide will result in a second time to progression that is as long or longer than the first time to progression

开始日期2006-12-31

申办/合作机构

EMD Serono, Inc.

100 项与 Tucotuzumab celmoleukin 相关的临床结果

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100 项与 Tucotuzumab celmoleukin 相关的转化医学

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100 项与 Tucotuzumab celmoleukin 相关的专利（医药）

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14

项与 Tucotuzumab celmoleukin 相关的文献（医药）

2022-11-01·Bioorganic Chemistry

Discovery of N-arylcinnamamides as novel erythroblast enucleation inducers

Article

作者: Zhao, Baobing ; Li, Yanxia ; Lu, Zhiyuan ; Lu, Chunhua ; Shen, Yuemao ; Xu, Guangsen

Derivation of mature red blood cells (RBCs) from stem cells in vitro is a promising solution to the current shortage of blood supply, in which terminal enucleation is the rate-limiting step. Here we discovered two cinnamamides B8 and B16 showed potential activities of enhancing the enucleation of erythroblasts through the screening of "in-house" compound library. Subsequently, twenty-four N-arylcinnamamides were rationally designed and synthesized on the basis of the structure of B8 and B16, in which N-(9H-carbazol-2-yl)cinnamamide (KS-2) significantly elevated the percentage of reticulocytes in the cultured mouse fetal liver cells in vitro (relative enucleation = 2.43). The underlying mechanism of KS-2 in promoting mouse erythroid enucleation is accelerating the process of cell cycle exit via p53 activation in late stage erythrocytes. These results strongly suggest that compound KS-2 is worthy of further study as a potential erythrocyte enucleation inducer.

2015-11-01·Anti-Cancer Drugs4区 · 医学

Cyclophosphamide and tucotuzumab (huKS-IL2) following first-line chemotherapy in responding patients with extensive-disease small-cell lung cancer

4区 · 医学

Article

作者: Krzakowski, Maciej J. ; Komarnitsky, Philip B. ; Serwatowski, Piotr ; Ramlau, Rodryg ; Milanowski, Janusz ; Kramer, Daniel ; Gladkov, Oleg ; Tomeczko, Janusz

The humanized KS-interleukin-2, tucotuzumab (huKS-IL2; EMD 273066), is an EpCAM-specific immunocytokine with reported immunologic activity in combination with cyclophosphamide. This Phase 2, randomized, open-label study compared tucotuzumab/cyclophosphamide, administered as maintenance, with best supportive care (BSC) in patients with extensive-disease small-cell lung cancer (ED-SCLC) who responded to first-line platinum-based chemotherapy with/without prophylactic cranial irradiation (PCI). Patients received cyclophosphamide (300 mg/m, Day 1 of every 3-week cycle), followed by tucotuzumab (1.5 mg/m, Days 2-4) until disease progression. The primary endpoint was 6-month progression-free survival (PFS); the secondary objectives included overall survival (OS), treatment response, and safety. The 6-month PFS rate was lower in the tucotuzumab/cyclophosphamide group (n=64) than in the BSC group (n=44): 6.4 versus 12.2% [hazard ratio (HR): 0.98; 80% confidence interval (CI): 0.74-1.31]. HRs for PFS, time to progression, and OS indicated a similar risk of disease progression and death in both groups and best overall responses were generally comparable. For patients with previous PCI (n=26), there was a nonsignificant trend toward prolonged median PFS (1.7 vs. 1.5 months; HR: 0.60; 80% CI: 0.33-1.11) and OS (21.5 vs. 14.3 months; HR: 0.58; 80% CI: 0.31-1.05) in the tucotuzumab/cyclophosphamide group. Adverse events were more frequent with tucotuzumab/cyclophosphamide (92.2%) than with BSC (47.7%). Tucotuzumab/cyclophosphamide was well tolerated in ED-SCLC patients, but did not show PFS or OS benefits compared with BSC. The observed trend toward prolonged PFS and OS in the subgroup of patients receiving previous PCI may support further confirmation in a larger population.

2013-12-01·BMC Cancer2区 · 医学

A phase 1b study of humanized KS-interleukin-2 (huKS-IL2) immunocytokine with cyclophosphamide in patients with EpCAM-positive advanced solid tumors

2区 · 医学

ArticleOA

作者: Jean Henslee-Downey ; Lionel D Lewis ; Sarah Stewart ; Nancy L Lewis ; Daniel Kramer ; Josephine Harter ; Roger Stupp ; Roland Neugebauer ; Philip B Komarnitsky ; Maria R Mattiacci ; Joseph P Connor ; Mildred Felder ; Mihaela C Cristea

BACKGROUNDHumanized KS-interleukin-2 (huKS-IL2), an immunocytokine with specificity for epithelial cell adhesion molecule (EpCAM), has demonstrated favorable tolerability and immunologic activity as a single agent.METHODSPhase 1b study in patients with EpCAM-positive advanced solid tumors to determine the maximum tolerated dose (MTD) and safety profile of huKS-IL2 in combination with low-dose cyclophosphamide. Treatment consisted of cyclophosphamide (300 mg/m2 on day 1), and escalating doses of huKS-IL2 (0.5-4.0 mg/m2 IV continuous infusion over 4 hours) on days 2, 3, and 4 of each 21-day cycle. Safety, pharmacokinetic profile, immunogenicity, anti-tumor and biologic activity were evaluated.RESULTSTwenty-seven patients were treated for up to 6 cycles; 26 were evaluable for response. The MTD of huKS-IL2 in combination with 300 mg/m2 cyclophosphamide was 3.0 mg/m2. At higher doses, myelosuppression was dose-limiting. Transient lymphopenia was the most common grade 3/4 adverse event (AE). Other significant AEs included hypotension, hypophosphatemia, and increase in serum creatinine. All patients recovered from these AEs. The huKS-IL2 exposure was dose-dependent, but not dose-proportional, accumulation was negligible, and elimination half-life and systemic clearance were independent of dose and time. Most patients had a transient immune response to huKS-IL2. Immunologic activity was observed at all doses. Ten patients (38%) had stable disease as best response, lasting for ≥ 4 cycles in 3 patients.CONCLUSIONThe combination of huKS-IL2 with low-dose cyclophosphamide was well tolerated. Although no objective responses were observed, the combination showed evidence of immunologic activity and 3 patients showed stable disease for ≥ 4 cycles.

100 项与 Tucotuzumab celmoleukin 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09027	Tucotuzumab celmoleukin	-	DB15402

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性卵巢癌	临床2期	-	EMD Serono, Inc.	2006-12-31
非小细胞肺癌	临床2期	美国	EMD Serono, Inc.	2005-05-01
膀胱癌	临床2期	美国	EMD Serono, Inc.	2000-12-01
难治性癌症	临床2期	美国	EMD Serono, Inc.	2000-12-01
卵巢癌	临床2期	美国	EMD Lexigen Research Center Corp.	-
卵巢癌	临床2期	美国	EMD Lexigen Research Center Corp.	-
小细胞肺癌	临床2期	-	EMD Lexigen Research Center Corp.	-
小细胞肺癌	临床2期	美国	Merck KGaA	-
小细胞肺癌	临床1期	-	Merck Serono SA	-
肾肿瘤	药物发现	美国	EMD Serono, Inc.	2000-12-01

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临床结果

适应症

分期

评价

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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


NCT00132522 (Pubmed \| BMC Cancer)	临床1期	EpCAM阳性实体瘤	45	huKS-IL2	(夢製願醖範艱鏇築鏇鑰) = The combination of huKS-IL2 with low-dose cyclophosphamide was well tolerated. Although no objective responses were observed, the combination showed evidence of immunologic activity and 3 patients showed stable disease for ≥ 4 cycles 鬱憲鑰衊糧繭艱構願遞 (選鏇遞壓積鹹膚餘網遞 ) 更多	-	2013-01-15
ASCO2011	临床1期	EpCAM阳性实体瘤	27	EMD 273066 (huKS-IL2) + cyclophosphamide	(淵艱齋積壓獵糧範顧願) = 選襯選簾鑰願積願壓醖壓廠壓窪鹹醖鹹衊構製 (範選積糧襯範衊鑰鑰壓 ) 更多	-	2011-05-20