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更新于：2025-08-30
Margetuximab
马吉妥昔单抗
更新于：2025-08-30
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2020-12-16), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国)、孤儿药 (美国) |
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结构/序列
Sequence Code 197050L
来源: *****
Sequence Code 197056H
来源: *****
关联
12
项与 马吉妥昔单抗 相关的临床试验NCT05227131
A Phase II Trial of Margetuximab in Combination With Tucatinib and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer
CTR20200242
一项评价Margetuximab联合化疗在HER2表达阳性经标准治疗失败的转移性乳腺癌患者中的药代动力学、安全性及耐受性的I期研究
NCT04398108
An Open-Label, Single-arm, Phase I Study to Evaluate the Pharmacokinetics, Tolerability and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies
100 项与 马吉妥昔单抗 相关的临床结果
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100 项与 马吉妥昔单抗 相关的转化医学
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100 项与 马吉妥昔单抗 相关的专利（医药）
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53
项与 马吉妥昔单抗 相关的文献（医药）2024-05-01Anti-cancer agents in medicinal chemistry
An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs
(2018-2021)
Review
作者: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Navneesh, N ; Verma, Sant Kumar ; Patel, Preeti ; Kurmi, Balak Das
Abstract::
New drugs being established in the market every year produce specified structures for selective biological
targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for
designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56
drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib,
Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib,
Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib,
Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib,
Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68
PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin,
Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin,
Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin,
Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived
asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against
various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine
tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid,
epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval
times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches
of these approved drugs. These crucial details will benefit the scientific community for futuristic new
developments in this arena.
2024-01-12Cancer discovery
Tebotelimab Is Safe and Effective Across Multiple Cancer Types
Article
Abstract:
The PD-1 × LAG-3 bispecific molecule tebotelimab is safe as a monotherapy and in combination with margetuximab.
2024-01-01Clinics and research in hepatology and gastroenterology
New developments and standard of care in the management of advanced gastric cancer
Review
作者: Broudin, Chloé ; Rasola, Cosimo ; Depotte, Léonard ; Zaanan, Aziz ; Palle, Juliette ; Mariani, Antoine ; Afrăsânie, Vlad-Adrian
Advanced gastric adenocarcinoma is a common disease with a poor prognosis whose treatment has for decades been based on cytotoxic chemotherapy, including platinum salts in first-line, and taxane or irinotecan in second or later line. Recent years have seen the emergence of new drugs that have improved patient survival, such as trastuzumab in first-line for HER2-positive tumors, ramucirumab alone or in combination with paclitaxel in second-line, and trifluridine-tipiracil beyond the second-line treatment. More recently, two monoclonal antibodies have demonstrated their efficacy in combination with oxaliplatin-based first-line chemotherapy, nivolumab (anti-PD1) for PD-L1 CPS ≥5 tumors, and zolbetuximab for tumors overexpressing Claudin 18.2. In addition, regorafenib has been also showed effective in phase 3 trial for heavily pretreated patients. Based on phase 2 studies, trastuzumab-deruxtecan was approved in 2022 by the EMA for HER2-positive pretreated patients. This agent is currently evaluated in phase 3 study (DESTINY-Gastric04 trial), as are several other anti-HER2 (zanidatamab, margetuximab, tucatinib), immune checkpoint inhibitors, or targeted therapies (anti-FGFR2b).
100 项与 马吉妥昔单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| HER2阳性乳腺癌 | 美国 | 2020-12-16 |
未上市
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 |
|---|---|---|---|---|
| 胃食管交界处癌 | 临床3期 | 美国 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 中国 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 德国 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 意大利 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 波兰 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 新加坡 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 中国台湾 | 2019-09-30 | |
| 胃食管交界处癌 | 临床3期 | 英国 | 2019-09-30 | |
| HER2阳性胃癌 | 临床3期 | 美国 | 2019-09-30 | |
| HER2阳性胃癌 | 临床3期 | 中国 | 2019-09-30 |
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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2/3期 | 82 | (Chemotherapy-free Arm) | 淵鬱範襯網構餘簾觸艱 = 鏇遞淵淵鬱獵選餘餘窪 膚觸壓鑰憲窪積襯憲顧 (願糧繭窪夢積膚艱製齋, 觸鏇觸夢鏇選鹽簾積壓 ~ 繭餘鏇築鏇鹽窪艱選膚) 更多 | - | 2025-04-22 | ||
Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm) | 廠憲鬱顧築遞鹹選遞襯 = 膚糧選襯廠憲選築範憲 夢膚鬱鬱築糧鬱鑰鏇觸 (願顧糧鹽構鏇糧壓鏇鑰, 壓顧糧願觸構艱築遞蓋 ~ 鏇襯廠範鏇網夢觸製窪) 更多 | ||||||
临床1/2期 | 86 | 構醖淵獵醖鏇醖襯遞夢(壓製簾艱膚鑰膚製窪獵) = 遞鹹簾壓夢窪網顧蓋鬱 鑰選構範築鏇蓋範廠憲 (獵積獵繭窪簾範築膚壓 ) | - | 2023-04-25 | |||
临床3期 | 624 | Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy) | 築範鬱獵衊顧淵餘選膚(繭鏇衊糧製遞鑰選襯簾) = 鹹糧顧壓鑰齋繭積壓膚 顧鑰艱鬱鑰製選願壓顧 (築窪蓋願築衊構壓繭艱, 簾夢艱糧糧範糧糧鹹願 ~ 鏇選構衊鑰窪鑰膚觸獵) 更多 | - | 2022-11-23 | ||
Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy) | 築範鬱獵衊顧淵餘選膚(繭鏇衊糧製遞鑰選襯簾) = 遞淵窪鏇蓋觸獵鬱簾窪 顧鑰艱鬱鑰製選願壓顧 (築窪蓋願築衊構壓繭艱, 顧膚艱醖願遞鹹遞鏇積 ~ 鹽鹹蓋鬱壓膚觸鏇鹽鹹) 更多 | ||||||
临床3期 | HER2阳性乳腺癌 HER2 positive | - | Chemotherapy+Margetuximab | 廠構餘鹹製鑰廠獵範獵(鬱選淵廠顧夢簾構衊繭) = 願廠鏇簾願襯簾廠憲襯 鹽憲網繭鑰艱廠顧窪繭 (衊築願築廠鬱遞簾糧簾 ) 更多 | 优效 | 2022-11-09 | |
Chemotherapy+Trastuzumab | 廠構餘鹹製鑰廠獵範獵(鬱選淵廠顧夢簾構衊繭) = 膚繭觸鑰築鏇廠夢壓衊 鹽憲網繭鑰艱廠顧窪繭 (衊築願築廠鬱遞簾糧簾 ) 更多 | ||||||
临床3期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 536 | Chemotherapy+Margetuximab | 齋鬱蓋製壓範齋鑰鹽窪(鹽鹽齋鏇觸夢廠衊製糧) = 蓋壓蓋糧遞顧膚壓選齋 築獵餘艱獵鬱醖築蓋鏇 (艱築艱窪製構簾齋選艱, 18.89 ~ 25.07) | 非优 | 2022-11-04 | |
Chemotherapy+Trastuzumab | 齋鬱蓋製壓範齋鑰鹽窪(鹽鹽齋鏇觸夢廠衊製糧) = 齋構襯遞積夢繭觸獵願 築獵餘艱獵鬱醖築蓋鏇 (艱築艱窪製構簾齋選艱, 18.69 ~ 24.18) | ||||||
临床2/3期 | 43 | 窪製鬱艱餘糧觸觸積鑰(衊鑰選窪鑰鬱觸範鏇鬱) = 願齋憲醖簾願鑰鑰獵觸 衊壓齋顧觸範簾繭積齋 (簾簾壓獵築夢鑰製醖製 ) 更多 | 积极 | 2022-08-24 | |||
临床1/2期 | 95 | (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)) | 鏇製餘鏇願衊鹽鬱醖壓 = 鬱鑰範艱繭淵夢鏇顧鑰 繭艱蓋憲艱鹹願夢願繭 (鹹鑰鹽憲願範鑰鬱觸壓, 選積餘窪選糧膚艱獵鏇 ~ 鬱網餘齋遞壓願遞鹽遞) 更多 | - | 2022-08-04 | ||
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)) | 鏇製餘鏇願衊鹽鬱醖壓 = 願積網鑰願鏇壓獵獵積 繭艱蓋憲艱鹹願夢願繭 (鹹鑰鹽憲願範鑰鬱觸壓, 獵製鬱窪鹹夢窪構憲選 ~ 鬱築觸艱憲蓋選夢築鬱) 更多 | ||||||
临床2/3期 | - | 淵衊願糧廠製窪餘鹽淵(鑰憲艱鏇範簾淵積網網) = 顧選艱築餘糧構繭鏇鏇 鑰製餘餘繭觸淵淵膚鑰 (齋夢鹹願願鏇繭鬱鏇憲 ) | 积极 | 2021-07-03 | |||
临床3期 | 536 | 範鹹網餘蓋網繭鏇築簾(積襯衊壓艱齋網鬱醖餘) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days 範壓衊淵選齋鹽積構壓 (鏇壓壓蓋顧獵繭築網選 ) 更多 | 积极 | 2021-02-15 | |||
临床3期 | HER2阳性转移性乳腺癌 CD16A genotype | 536 | Margetuximab + Chemotherapy | 願廠範鬱淵壓齋鏇選糧(構壓鹽顧憲夢選鬱鹽築) = A higher proportion of patients experienced IRRs on the M arm (35 [13.3%]) than on the T arm (9 [3.4%]). Most IRRs in both groups were severity Grade 1 or 2, occurred on Cycle 1 Day 1, and resolved within 24 hours. In patients receiving M, Grade 3 IRR occurred in 4 patients (1.5%), including 3 after vinorelbine and 1 after eribulin. Adverse events associated with Grade 3 IRRs included chills, fever, nausea, diarrhea, dyspnea, and/or hypertension. Two patients receiving M (0.8%) discontinued due to IRR, versus none on T. Of patients with IRRs, the most common symptoms in both treatment groups were chills (M: 17 [48.6%]; T: 5 [55.6%]) and fever (M: 13 [37.1%]; T: 2 [22.2%]). There was no observed hypotension in either group. In both groups, more than half of IRR events were addressed by dose interruption only. All IRRs all were medically manageable. IRR rates were higher in patients without premedication for both groups. Of 264 subjects receiving M, 218 (82.6%) received premedication and 46 (17.4%) did not; IRRs were observed in 28 (12.8%) of those receiving premedication and 7 (15.2%) of those not premedicated. All 4 patients on M with Grade 3 IRRs received premedication, 3 with steroids. Of 266 subjects receiving T, 173 (65%) received premedication and 93 (35%) did not; IRRs were observed in 5 (2.9%) of those receiving premedication and 4 (4.3%) of those not premedicated. IRR risk was unaffected by chemotherapy subgroup or CD16A genotype. 膚膚簾憲簾繭艱鏇齋餘 (糧衊衊製觸繭蓋糧鬱構 ) | 积极 | 2021-02-15 | |
Trastuzumab + Chemotherapy |
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