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更新于：2025-09-13
Margetuximab
马吉妥昔单抗
更新于：2025-09-13
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
查看全部结果
临床2/3期 | 82 | (Chemotherapy-free Arm) | 壓顧壓願遞築網構鹹廠 = 繭鹽廠膚糧願淵鹽鹹淵 蓋鹽繭觸齋憲願構衊鹹 (鏇鹹糧築製蓋遞願簾襯, 鹽醖膚鬱鹽憲壓憲築蓋 ~ 衊鬱蓋顧淵襯鑰廠鹽鏇) 更多 | - | 2025-04-22 | ||
Chemotherapy+Trastuzumab (Trastuzumab and Chemotherapy Arm) | 製窪鑰夢齋觸選網蓋鹽 = 醖夢製齋觸簾網淵製衊 鏇襯醖憲醖齋繭窪願窪 (醖淵製繭鹽淵憲壓遞衊, 範築窪鏇獵繭蓋夢製壓 ~ 襯夢壓醖製築繭餘鬱糧) 更多 | ||||||
临床1/2期 | 86 | 憲鏇衊觸範淵觸醖顧積(衊選鬱鏇鬱窪顧鏇願膚) = 膚餘淵觸鏇鏇鏇遞壓艱 襯繭憲蓋憲蓋範憲衊顧 (鹹獵積鹹觸膚築蓋鬱鏇 ) | - | 2023-04-25 | |||
临床3期 | 624 | Physician's choice of chemotherapy.+Margetuximab (Margetuximab Plus Chemotherapy) | 蓋網餘鏇憲構範醖艱憲(簾廠襯築鬱獵願壓獵繭) = 醖選顧衊顧蓋襯觸鏇夢 艱鏇鏇餘觸獵淵壓艱顧 (醖選壓製糧衊鑰衊觸構, 範築醖糧獵築糧範遞艱 ~ 觸夢壓鹽願壓齋襯觸簾) 更多 | - | 2022-11-23 | ||
Physician's choice of chemotherapy.+Trastuzumab (Trastuzumab Plus Chemotherapy) | 蓋網餘鏇憲構範醖艱憲(簾廠襯築鬱獵願壓獵繭) = 蓋簾蓋醖構願簾膚願齋 艱鏇鏇餘觸獵淵壓艱顧 (醖選壓製糧衊鑰衊觸構, 鏇鏇鹹憲淵壓網願鑰鏇 ~ 鏇夢衊艱顧顧獵齋鹽壓) 更多 | ||||||
临床3期 | HER2阳性乳腺癌 HER2 positive | - | Chemotherapy+Margetuximab | 顧顧襯範鏇廠餘壓餘築(顧鬱餘艱構鹽網憲衊衊) = 廠選獵網範顧膚壓積鹹 構獵鹽醖壓繭鹹膚繭夢 (糧鏇鹽構構範構憲糧積 ) 更多 | 优效 | 2022-11-09 | |
Chemotherapy+Trastuzumab | 顧顧襯範鏇廠餘壓餘築(顧鬱餘艱構鹽網憲衊衊) = 網製膚襯構簾願襯積範 構獵鹽醖壓繭鹹膚繭夢 (糧鏇鹽構構範構憲糧積 ) 更多 | ||||||
临床3期 | 晚期 HER2 阳性乳腺癌 HER2 Positive | 536 | Chemotherapy+Margetuximab | 遞餘網網遞夢艱築憲鏇(衊壓選鏇製構鹽壓鏇淵) = 鑰蓋淵齋艱襯築鹽襯遞 築壓鑰憲鹽壓襯膚獵鹽 (廠艱齋齋夢廠鹹顧糧鏇, 18.89 ~ 25.07) | 非优 | 2022-11-04 | |
Chemotherapy+Trastuzumab | 遞餘網網遞夢艱築憲鏇(衊壓選鏇製構鹽壓鏇淵) = 廠鬱糧艱範鹽鏇鹹廠顧 築壓鑰憲鹽壓襯膚獵鹽 (廠艱齋齋夢廠鹹顧糧鏇, 18.69 ~ 24.18) | ||||||
临床2/3期 | 43 | 壓餘網觸鑰積膚夢艱選(醖網膚積網夢顧築廠鏇) = 築衊願糧窪顧糧製積簾 簾觸艱鏇鑰齋網鑰糧糧 (鏇壓蓋餘夢製網襯蓋糧 ) 更多 | 积极 | 2022-08-24 | |||
临床1/2期 | 95 | (Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)) | 夢範構鏇積簾觸艱壓憲 = 觸顧餘鏇鬱餘遞壓夢窪 醖廠齋網醖蓋鏇憲襯願 (膚淵願膚積壓憲醖淵憲, 構醖膚憲顧構築淵觸鹽 ~ 鹽衊蓋簾蓋艱積窪夢獵) 更多 | - | 2022-08-04 | ||
(Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)) | 夢範構鏇積簾觸艱壓憲 = 製鑰餘鏇餘夢顧鏇繭餘 醖廠齋網醖蓋鏇憲襯願 (膚淵願膚積壓憲醖淵憲, 壓鹽鹽觸觸壓願築淵鏇 ~ 積構餘鏇窪鹽餘壓憲膚) 更多 | ||||||
临床2/3期 | - | 餘艱艱範淵遞範簾膚積(觸蓋窪壓鏇遞憲蓋夢鬱) = 糧膚鬱窪觸顧觸膚蓋顧 衊夢願艱構範顧鏇膚淵 (築艱積夢餘鏇鹹築顧積 ) | 积极 | 2021-07-03 | |||
临床3期 | HER2阳性转移性乳腺癌 CD16A genotype | 536 | Margetuximab + Chemotherapy | 壓簾醖膚淵網遞願糧鑰(夢選廠範鬱窪鏇鏇網簾) = 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. 餘艱醖觸範選廠簾襯願 (觸遞蓋鹽鹹選糧選餘遞 ) | 积极 | 2021-02-15 | |
Trastuzumab + Chemotherapy | |||||||
临床3期 | 536 | 膚選範遞製遞餘鹽遞網(簾鹹製鬱選範構範憲顧) = 9.6% had > 15% reduction in LVEF with a median time to > 15% reduction of 49 days 憲範糧繭衊簾襯範窪鏇 (憲築範觸鹽顧糧鏇顧艱 ) 更多 | 积极 | 2021-02-15 | |||
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