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更新于：2026-02-27
Trastuzumab vedotin
更新于：2026-02-27
概要
基本信息
原研机构 |
在研机构- |
非在研机构 |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)终止 |
特殊审评孤儿药 (美国) |
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结构/序列
分子式C11H22N4O4 |
InChIKeyAGGWFDNPHKLBBV-YUMQZZPRSA-N |
CAS号159858-33-0 |
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Sequence Code 18481L
来源: *****
Sequence Code 44772H
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关联
13
项与 Trastuzumab vedotin 相关的临床试验NCT06869174
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pucotenlimab in Combination with MRG002 in Treating HER2-positive Cancer of Unknown Primary
ChiCTR2400086422
MRG 002 for her2 positive advanced paget’s disease: a phase II trial.
CTR20230243
MRG002对比研究者选择化疗治疗既往接受过含铂化疗和PD 1/PD-L1抑制剂治疗的无法手术切除的HER2阳性局部晚期或转移性尿路上皮癌的随机、开放、多中心III期临床试验
100 项与 Trastuzumab vedotin 相关的临床结果
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100 项与 Trastuzumab vedotin 相关的转化医学
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100 项与 Trastuzumab vedotin 相关的专利（医药）
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372
项与 Trastuzumab vedotin 相关的文献（医药）2025-12-31mAbs
A bispecific antibody-drug conjugate targeting pCAD and CDH17 has antitumor activity and improved tumor-specificity
作者: Gesner, Thomas ; Logel, Claude ; Xie, Kathleen T. ; Cebe, Regis ; Wu, Nila C. ; Li, Xun ; Shi, Xingyi ; Velazquez, Roberto ; Simmons, Quincey ; Tschantz, William R. ; Korn, Joshua ; Barzaghi-Rinaudo, Patrizia ; Sagar, Vivek ; Hainzl, Dominik ; Malamas, Anthony ; Mercan, Samuele ; Green, Andrew ; McLaughlin, Margaret ; Huber, Thomas ; Mueller, Kathrin ; D’Alessio, Joseph A. ; Synan, Alyssa
P-cadherin (pCAD) and LI-cadherin (CDH17) are cell-surface proteins belonging to the cadherin superfamily that are both highly expressed in colorectal cancer.This co-expression profile presents a novel and attractive opportunity for a dual targeting approach using an antibody-drug conjugate (ADC).In this study, we used a unique avidity-driven in vitro screening approach to generate pCAD x CDH17 bispecific antibodies that selectively target cells expressing both antigens over cells expressing only pCAD or only CDH17.Based on in vitro binding and inhibition of cell proliferation results, we selected a lead bispecific antibody to link to the cytotoxic payload monomethyl auristatin E (MMAE) to generate a pCAD x CDH17 bispecific MMAE ADC.In in vivo dual flank mouse models, we demonstrated antitumor activity of the bispecific ADC in tumors expressing both antigens but not in tumors expressing only pCAD or only CDH17.Overall, the preclin. data presented here support the proof-of-concept bispecific antibody discovery approach, demonstrating a rational design for screening antibodies by prioritizing cross-arm avid IgGs to target dual-pos. cells.
2025-11-01EUROPEAN JOURNAL OF CANCER
Efficacy and safety of MRG002 monotherapy in treating patients with locally advanced or metastatic breast cancer with low HER2 expression: A multi-center, non-randomized, open-label phase II clinical trial
Article
作者: Pan, Yueyin ; Geng, Cuizhi ; Zhang, Shaohua ; Liu, Qiang ; Yin, Yongmei ; Yang, Hua ; Jiang, Zefei ; Wang, Xiaojia ; Tong, Zhongsheng ; Wang, Shusen ; Sun, Tao ; Wang, Jingfen ; Su, Wuyun ; Yan, Min ; Yu, Guohua
BACKGROUND:
MRG002 is a novel antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2), with a monomethyl auristatin E (MMAE) payload. This multicenter, non-randomized, open-label Phase II study was conducted to evaluate the efficacy and safety of MRG002 in patients with locally advanced or metastatic breast cancer with low HER2 expression.
METHODS:
Eligible patients had locally advanced or metastatic breast cancer with low HER2 expression (including both hormone receptor-positive and -negative subtypes) and had failed at least one line of standard therapy. MRG002 was administered intravenously at 2.6 mg/kg every 3 weeks. Imaging evaluations were performed every 6 weeks until treatment completion, initiation of a new anti-tumor therapy, withdrawal of informed consent, or death.
RESULTS:
As of the cutoff date (April 30, 2024), 56 patients were enrolled across 14 centers in China. The confirmed objective response rate (ORR) assessed by the Independent Review Committee (IRC) was 39.3 % (22 patients; 95 % CI, 26.5 %-53.2 %), and the disease control rate (DCR) was 73.2 % (95 % CI, 59.7 %-84.2 %). Median progression-free survival (PFS) was 5.8 months (95 % CI, 5.5-7.3). Overall survival (OS) data were immature; the 12-month OS rate was 79.9 % (95 % CI, 69.2 %-87.3 %). The most common Grade 3-4 treatment-related adverse events (TRAEs) occurring in ≥ 5 % of patients included decreased neutrophil count (17.9 %), decreased white blood cell count (8.9 %), and peripheral neuropathy (7.1 %). One patient experienced Grade 2 interstitial lung disease, and no drug-related deaths occurred.
CONCLUSIONS:
MRG002 demonstrated a manageable safety profile and promising anti-tumor activity in patients with locally advanced or metastatic breast cancer with low HER2 expression.
2025-06-12ACS Medicinal Chemistry Letters
Site-Selective Anti-PD-L1 Antibody–MMAE Conjugate for Enhanced NSCLC Therapy
Article
作者: Kwon, Se Jeong ; Son, Jinyoung ; Chung, Sang J.
Nonsmall cell lung cancer (NSCLC) presents significant therapeutic challenges, causing advancements in targeted therapies. We have developed a site-selective antibody-drug conjugate (ADC), durvalumab-monomethyl auristatin E (MMAE), with a drug-antibody ratio (DAR) of 4, specifically targeting programmed death-ligand 1 (PD-L1), aimed at enhancing NSCLC therapy. Utilizing the innovative AbClick Pro linker, this ADC ensures stable, site-specific conjugation of MMAE to durvalumab, preserving antibody functionality and integrity. In vivo studies demonstrate that durvalumab-MMAE achieves substantial tumor growth inhibition in NSCLC xenograft models, with an impressive tumor growth inhibition rate of over 60% at lower dosages without significant toxicity. These results, combined with a favorable pharmacokinetic profile featuring extended half-life and low clearance, highlight the potential of durvalumab-MMAE (DAR4) as a potent next-generation ADC for treating PD-L1-expressing cancers, offering a promising avenue for improved NSCLC patient outcomes.
100 项与 Trastuzumab vedotin 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| HER2阳性尿路上皮癌 | 临床3期 | 中国 | 2023-03-21 | |
| 晚期乳腺癌 | 临床3期 | 中国 | 2021-06-30 | |
| HER2阳性乳腺癌 | 临床3期 | 中国 | 2021-06-30 | |
| HER2阳性转移性乳腺癌 | 临床3期 | 中国 | 2021-06-30 | |
| 转移性非小细胞肺癌 | 临床2期 | 中国 | 2022-10-09 | |
| 可切除非小细胞肺癌 | 临床2期 | 中国 | 2022-10-09 | |
| 晚期 HER2 阳性乳腺癌 | 临床2期 | 中国 | 2022-03-23 | |
| 乳腺癌肝脏转移 | 临床2期 | 中国 | 2022-03-23 | |
| 肝转移 | 临床2期 | 中国 | 2022-03-04 | |
| 转移性 HER2 阳性胃食管结合部癌 | 临床2期 | 中国 | 2022-01-19 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | HER2阳性乳腺癌 HER2 Positive | 102 | MRG002 2.6 mg/kg | 簾醖壓鬱壓選蓋製憲窪(獵廠蓋淵願選淵遞構鑰) = 觸糧構積築淵憲襯構鹽 醖餘憲製鹹餘構醖膚簾 (鑰廠願簾蓋廠壓鹹築鏇, 50.6 ~ 70.3) 更多 | 积极 | 2024-11-26 | |
MRG002 2.6 mg/kg (HER2 IHC 3+) | 簾醖壓鬱壓選蓋製憲窪(積膚鹹遞艱餘網餘築餘) = 醖願繭簾願簾餘網繭壓 構鬱網憲繭簾顧鹹衊衊 (構積夢艱餘餘廠鏇壓鬱 ) 更多 | ||||||
临床1/2期 | 尿路上皮癌 HER2-expressing | 33 | 憲遞襯積顧廠簾廠觸醖(鑰選餘鹽願廠遞夢獵網) = 構鑰選餘憲餘襯積齋齋 淵鏇齋蓋廠獵製簾醖夢 (製選製鹽觸遞衊鏇鏇鏇 ) 更多 | 积极 | 2024-09-15 | ||
临床2期 | 43 | 簾觸鹹襯選簾廠夢繭醖(鹹衊憲積積範築積鏇鹽) = 31.8% 範艱顧觸選醖襯鑰鬱糧 (獵鬱鹹鏇積積鬱窪簾鏇 ) 更多 | 积极 | 2022-09-21 | |||
临床2期 | HER2阳性尿路上皮癌 HER2 Positive | 58 | 膚艱製窪構簾憲糧襯鬱(網衊餘遞築遞齋淵齋廠) = 蓋蓋築鏇範憲憲觸構繭 醖網選製積選鹹鑰觸襯 (鹹艱憲襯鹽齋鹽壓鑰鹽 ) 更多 | 积极 | 2022-08-25 | ||
(Platinum-containing chemotherapy and PD-(L)1 treatment failed) | 膚艱製窪構簾憲糧襯鬱(網衊餘遞築遞齋淵齋廠) = 廠鏇鹽繭繭網艱鏇網襯 醖網選製積選鹹鑰觸襯 (鹹艱憲襯鹽齋鹽壓鑰鹽 ) 更多 | ||||||
临床2期 | 不可切除的尿路上皮癌 HER2 Positive | 39 | 構觸淵構窪範糧觸齋衊(憲觸製淵齋淵網築鏇選) = 糧餘範構願構夢鬱醖獵 衊夢觸糧願餘壓憲膚鬱 (觸簾選範淵襯築獵簾齋, 44.9 ~ 81.2) 更多 | 积极 | 2022-06-02 | ||
(≥ 2 lines of treatment) | 構觸淵構窪範糧觸齋衊(憲觸製淵齋淵網築鏇選) = 廠衊襯觸築鹽糧觸蓋鹽 衊夢觸糧願餘壓憲膚鬱 (觸簾選範淵襯築獵簾齋 ) | ||||||
临床2期 | HER2低表达乳腺癌 HER2 Lowexpression | 56 | 鑰選齋範齋築蓋艱簾鬱(窪廠夢網積鏇鑰憲膚積) = 簾選憲網範餘獵憲觸鹽 獵窪繭衊鹽鹽醖選齋選 (夢膚壓鑰網積蓋顧遞範 ) 更多 | 积极 | 2022-06-02 | ||
(patients with visceral metastasis) | 鑰選齋範齋築蓋艱簾鬱(窪廠夢網積鏇鑰憲膚積) = 醖鏇餘鹽獵廠積積淵鬱 獵窪繭衊鹽鹽醖選齋選 (夢膚壓鑰網積蓋顧遞範 ) 更多 |
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