Umikibart(Umikibart) - 药物靶点：HGF_在研适应症：结直肠癌，卵巢癌，胰腺癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

+ [1]

靶点

HGF

作用机制

HGF抑制剂(肝细胞生长因子抑制剂)

治疗领域

肿瘤消化系统疾病内分泌与代谢疾病+ [1]

在研适应症

结直肠癌卵巢癌胰腺癌

非在研适应症

晚期恶性实体瘤复发性结直肠癌转移性结直肠癌

原研机构

Yooyoung Pharm Co. Ltd.

在研机构

Cell Lab Med初创企业

非在研机构

Yooyoung Pharm Co. Ltd.

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 1116814770L

来源: *****

Sequence Code 1116814769H

来源: *****

关联

2

项与 Umikibart 相关的临床试验

NCT04368507

/ Completed临床1/2期

A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of YYB101, Hepatocyte Growth Factor (HGF)-Neutralizing Humanized Monoclonal Antibody (Mab) in Combination With Irinotecan in Metastatic or Recurrent Colorectal Cancer Patients

To evaluate the safety, tolerability, pharmacokinetics and antitumor activity of YYB101 with Irinotecan, patients who are metastatic or recurrent Colorectal Cancer Patients.

开始日期2019-08-09

申办/合作机构

Cell Lab Med初创企业

[+1]

NCT02499224

/ Completed临床1期

A Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of YYB101, Hepatocyte Growth Factor (HGF)-Neutralizing Humanized Monoclonal Antibody (Mab), in Advanced Solid Tumors Patients Who Are Refractory to Standard Therapy

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and maximum tolerated dose (MTD) of YYB101, HGF-neutralizing humanized Mab, in advanced solid tumors patients who are refractory to standard therapy.

开始日期2015-07-13

申办/合作机构

Cell Lab Med初创企业

100 项与 Umikibart 相关的临床结果

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100 项与 Umikibart 相关的转化医学

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100 项与 Umikibart 相关的专利（医药）

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8

项与 Umikibart 相关的文献（医药）

2021-02-01·Anticancer Research4区 · 医学

YYB-101, a Humanized Antihepatocyte Growth Factor Monoclonal Antibody, Inhibits Ovarian Cancer Cell Motility and Proliferation

4区 · 医学

Article

作者: Kim, Hyun Jung ; Heo, Kyun

BACKGROUND/AIMHepatocyte growth factor (HGF) acts as a key regulator in promoting ovarian cancer metastasis. Previously, we observed that YYB-101, a humanized anti-HGF antibody, effectively inhibits ovarian cancer cell migration, invasion, and progression. Here, we evaluated the signaling mechanisms affected by YYB-101 that are important in ovarian cancer cell progression.MATERIALS AND METHODSUsing cell migration, invasion and proliferation assays, we evaluated the effects of YYB-101 on A2780/luc and SKOV3 cells. The effects of YYB-101 on signaling molecules were determined by immunocytochemistry and immunoblot analysis.RESULTSYYB-101 inhibited HGF-induced ovarian cancer cell motility by down-regulating paxillin phosphorylation and actin-cytoskeleton rearrangement. Also, YYB-101 inhibited ovarian cancer cell proliferation by reducing c-MET phosphorylation and activating apoptosis in vitro and in vivo. These effects were significantly enhanced by combining YYB-101 treatment with paclitaxel, a standard chemotherapy drug.CONCLUSIONYYB-101 can be examined as a new therapeutic agent for the treatment of patients with ovarian cancer.

2020-01-01·Therapeutic Advances in Medical Oncology2区 · 医学

First-in-human phase I trial of anti-hepatocyte growth factor antibody (YYB101) in refractory solid tumor patients

2区 · 医学

ArticleOA

作者: Lee, Jeeyun ; Park, Neunggyu ; Hong, Sung Hee ; Kim, Kyoung-Mee ; Park, Joon Oh ; Kim, Seung Tae ; Kang, Won Ki ; Lee, Jeong-Won ; Nam, Do-Hyun ; Park, Se Hoon ; Park, Young Whan ; Park, Keunchil ; Lee, Song-Jae ; Hong, Jung Yong ; Kim, Kyung ; Lim, Ho Yeong ; Lee, Hukeun ; Song, Seong-Won ; Park, Young Suk

Background: YYB101, a humanized monoclonal antibody against hepatocyte growth factor (HGF), has shown safety and efficacy in vitro and in vivo. This is a first-in-human trial of this antibody. Materials and Methods: YYB101 was administered intravenously to refractory cancer patients once every 4 weeks for 1 month, and then once every 2 weeks until disease progression or intolerable toxicity, at doses of 0.3, 1, 3, 5, 10, 20, 30 mg/kg, according to a 3+3 dose escalation design. Maximum tolerated dose, safety, pharmacokinetics, and pharmacodynamics were studied. HGF, MET, PD-L1, and ERK expression was evaluated for 9 of 17 patients of the expansion cohort (20 mg/kg). Results: In 39 patients enrolled, no dose-limiting toxicity was observed at 0.3 mg/kg, and the most commonly detected toxicity was generalized edema ( n = 7, 18.9%) followed by pruritis and nausea ( n = 5, 13.5%, each), fatigue, anemia, and decreased appetite ( n = 4, 10.8%, each). No patient discontinued treatment because of adverse events. YYB101 showed dose-proportional pharmacokinetics up to 30 mg/kg. Partial response in 1 (2.5%) and stable disease in 17 (43.5%) were observed. HGF, MET, PD-L1, and ERK proteins were not significant predictors for treatment response. However, serum HGF level was significantly lowered in responders upon drug administration. RNA sequencing revealed a mesenchymal signature in two long-term responders. Conclusion: YYB101 showed favorable safety and efficacy in patients with refractory solid tumors. Based on this phase I trial, a phase II study on the YYB101 + irinotecan combination in refractory metastatic colorectal cancer patients is planned. Conclusion: ClinicalTrials.gov Identifier: NCT02499224

2019-02-14·Neuro-Oncology1区 · 医学

Identification of genomic and molecular traits that present therapeutic vulnerability to HGF-targeted therapy in glioblastoma

1区 · 医学

Article

作者: Sa, Jason K ; Shin, Hyemi ; Joo, Kyeung Min ; Song, Seong-Won ; Lee, Mijeong ; Nam, Do-Hyun ; Hong, Sung Hee ; Koo, Harim ; Park, Young-Whan ; Cho, Hee Jin ; Lee, Jin-Ku ; Lee, Song-Jae ; Kim, Donggeon ; Shin, Yong Jae ; Kim, Sung Heon ; Kim, Jung Yong ; Kang, Wonyoung

BACKGROUNDCancer is a complex disease with profound genomic alterations and extensive heterogeneity. Recent studies on large-scale genomics have shed light on the impact of core oncogenic pathways, which are frequently dysregulated in a wide spectrum of cancer types. Aberrant activation of the hepatocyte growth factor (HGF) signaling axis has been associated with promoting various oncogenic programs during tumor initiation, progression, and treatment resistance. As a result, HGF-targeted therapy has emerged as an attractive therapeutic approach. However, recent clinical trials involving HGF-targeted therapies have demonstrated rather disappointing results. Thus, an alternative, in-depth assessment of new patient stratification is necessary to shift the current clinical course.METHODSTo address such challenges, we have evaluated the therapeutic efficacy of YYB-101, an HGF-neutralizing antibody, in a series of primary glioblastoma stem cells (GSCs) both in vitro and in vivo. Furthermore, we performed genome and transcriptome analysis to determine genetic and molecular traits that exhibit therapeutic susceptibility to HGF-mediated therapy.RESULTSWe have identified several differentially expressed genes, including MET, KDR, and SOX3, which are associated with tumor invasiveness, malignancy, and unfavorable prognosis in glioblastoma patients. We also demonstrated the HGF-MET signaling axis as a key molecular determinant in GSC invasion, and we discovered that a significant association in HGF expression existed between mesenchymal phenotype and immune cell recruitment.CONCLUSIONSUpregulation of MET and mesenchymal cellular state are essential in generating HGF-mediated therapeutic responses. Our results provide an important framework for evaluating HGF-targeted therapy in future clinical settings.

100 项与 Umikibart 相关的药物交易

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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
结直肠癌	临床2期	韩国	Cell Lab Med初创企业	-
卵巢癌	临床前	韩国	Cell Lab Med初创企业	2023-07-04
胰腺癌	临床前	韩国	Cell Lab Med初创企业	2023-07-04
复发性结直肠癌	临床前	韩国	Cell Lab Med初创企业	2019-08-09
复发性结直肠癌	临床前	韩国	Yooyoung Pharm Co. Ltd.	2019-08-09
转移性结直肠癌	临床前	韩国	Yooyoung Pharm Co. Ltd.	2019-08-09
转移性结直肠癌	临床前	韩国	Cell Lab Med初创企业	2019-08-09
晚期恶性实体瘤	临床前	韩国	Cell Lab Med初创企业	2015-07-13

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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


NCT04368507 (NOV110501-201, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	结直肠癌末线	35	YYB101+ irinotecan	(製鹽餘艱鑰鹹築願築製) = 獵廠廠遞壓獵選壓齋願膚餘顧襯壓簾網鹹遞鑰 (壓壓齋鏇築積鏇憲繭醖 ) 更多	积极	2023-10-22
NCT02499224 (Pubmed \| Ther Adv Med Oncol) 人工标引	临床1期	实体瘤	39	YYB101	(繭顧窪廠顧製選遞網鹽) = 網鏇窪網蓋鹽衊齋築衊壓鏇遞製鑰積鹹簾醖膚 (夢獵襯觸齋鏇築膚繭衊 ) 更多	积极	2020-06-02
NCT02499224 (ASCO2019)	临床1期	实体瘤	39	YYB101	(網積遞壓糧餘憲觸壓壓) = 廠糧築遞襯壓齋艱獵鹽鏇艱鬱襯顧齋醖膚糧獵 (構網壓醖蓋鹹範鑰觸窪 ) 更多	积极	2019-05-26
NCT02499224 (ASCO2018)	临床1期	难治恶性实体肿瘤	22	YYB101	壓顧築齋簾顧壓壓鏇範(築窪夢膚憲繭網襯簾糧) = anorexia, ALT increase, azotemia were observed at later dose 齋範願繭觸積蓋蓋鏇糧 (壓艱襯顧願膚鹹鹹顧窪 )	积极	2018-06-01