更新于：2024-04-26
Ramucirumab
雷莫西尤单抗
更新于：2024-04-26
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
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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序列信息
Sequence Code 9107105H
来源: *****
Sequence Code 9583823L
来源: *****
关联
247
项与 雷莫西尤单抗 相关的临床试验Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS >/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMMUNE)
A Randomized Phase II Study of Tepotinib With or Without Ramucirumab in Participants With MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP SUB-STUDY)
A Randomized Phase II Study of Paclitaxel and Ramucirumab +/- Zanidatamab in HER2 Positive Advanced Gastroesophageal Adenocarcinoma
100 项与 雷莫西尤单抗 相关的临床结果
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100 项与 雷莫西尤单抗 相关的转化医学
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100 项与 雷莫西尤单抗 相关的专利（医药）
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1,202
项与 雷莫西尤单抗 相关的文献（医药）2024-03-01Pediatric Blood & Cancer
A phase 1 trial utilizing a pharmacokinetic endpoint to determine the optimal dose of ramucirumab in children and adolescents with relapsed or refractory solid tumors, including central nervous system tumors
Article
作者: Croop, James ; Pilbeam, Kristy L ; Liu, Xiaowei ; Reid, Joel M ; Minard, Charles G ; Isikwei, Emasenyie ; Weigel, Brenda J ; Voss, Stephan D ; Berg, Stacey L ; Pradhan, Kamnesh ; Fox, Elizabeth
Abstract:
Background:
Ramucirumab is a monoclonal antibody that binds the extracellular domain of vascular endothelial growth factor receptor (VEGFR‐2) and prevents binding of VEGF ligands. Based on population pharmacokinetic (PK) analysis and correlation with efficacy in adults, a target steady state trough concentration (Css,min) ≥ 50 µg/mL was established.
Procedures:
This phase 1 trial (ADVL1416) used a rolling six design and a PK primary endpoint to define the recommended phase 2 dose (RP2D) of ramucirumab in children with recurrent/refractory solid tumors. Two dose levels (DL) were planned (DL1: 8 mg/kg, DL2: 12 mg/kg administered intravenously [IV] every 2 weeks). Toxicity during the initial 6 weeks was used to assess maximum tolerated dose (MTD). Cycle 1 Day 42 trough (Cmin) ≥ 50 µg/mL was the target concentration for the PK endpoint. At the RP2D, cohorts for PK expansion and children with central nervous tumors were planned.
Results:
Twenty‐nine patients were enrolled; 28 were eligible; median age [range] = 13.5 [1–21] years; 22 were evaluable for the PK endpoint. Dose‐limiting proteinuria occurred at both DLs; however, the MTD was not exceeded. At DL2 (12 mg/kg), the median Day 42 Cmin (n = 16) was 87.8 µg/mL; 15 of 16 patients achieved a Cmin ≥ 50 µg/mL.
Conclusion:
Ramucirumab was well tolerated in children and adolescents with solid tumors. The RP2D for ramucirumab was 12 mg/kg IV every 2 weeks. This trial demonstrates the feasibility of incorporating a primary PK endpoint to determine dose escalation and the RP2D in children. Studies of ramucirumab in children with selected solid tumors are ongoing.
2024-02-01Clinical Journal of Gastroenterology
Gastric cancer with Fanconi anemia in adolescent and young adult patient diagnosed by comprehensive genome profiling using next-generation sequencing
Article
作者: Maeda, Hiromichi ; Utsunomiya, Masato ; Kitagawa, Hiroyuki ; Hanazaki, Kazuhiro ; Namikawa, Tsutomu ; Kurioka, Yusuke ; Seo, Satoru ; Munekage, Masaya ; Tanaka, Tomoki ; Yokota, Keiichiro ; Satake, Hironaga ; Kobayashi, Michiya
Recently, the results of gastric cancer treatment have improved; however, its characteristics in adolescents and young adults are not well known. We report the case of a patient with advanced gastric cancer, Fanconi anemia (FA), and primary biliary cholangitis. A 26-year-old woman visited a local physician complaining of epigastralgia. Esophagogastroduodenoscopy revealed edematous changes with poor distension and circumferential thickened folds with erosions in the gastric body. Biopsy results of the lesion specimens revealed poorly differentiated adenocarcinoma. Abdominal contrast-enhanced computed tomography revealed gastric wall with irregular thickness, several nodules in the peritoneal cavity, and a mass lesion in the right ovary. We diagnosed the patient with T4N2M1 stage IV gastric cancer accompanied by peritoneal and ovarian metastases and initiated nivolumab with S-1 plus oxaliplatin as the first-line treatment regimen. Because of immune-related adverse events after one course of systemic treatment, the regimen was changed to ramucirumab combined with nab-paclitaxel chemotherapy as the second-line treatment. After three cycles of weekly nab-paclitaxel with ramucirumab, the decreased platelet count did not recover, and her general condition gradually deteriorated. Comprehensive genome profiling using next-generation sequencing was performed to determine the feasibility of genotype-matched therapies. Alterations in FA complementation group A (FANCA) F1263del (49.1%) and E484Q (12.3%), which encode a key component of the multiprotein FA complex, were identified. The patient died 10 months after treatment initiation. In conclusion, when treating malignancies in adolescent and young adult patients, the genomic background should be considered.
2024-02-01Journal of Chromatography B
A robust and validated LC–MS/MS method for the quantification of ramucirumab in rat and human serum using direct enzymatic digestion without immunoassay
Article
作者: Chen, Chong ; Yu, Jing-Hua ; Wu, Ya-Li ; Xue, Ming-Zhen ; Li, Wei-Qiang ; Huang, Wen-Si ; Yuan, Ya-Li ; Yu, Xiong ; Diao, Xing-Xing
A new liquid chromatography tandem mass spectrometry (LC-MS/MS) method was established to quantify the anti-gastric cancer fully human monoclonal antibody (ramucirumab) in rat and human serum. The surrogate peptide (GPSVLPLAPSSK) for ramucirumab was generated by trypsin hydrolysis and quantified using the isotopically labeled peptide GPSVLPLAPSSK[13C6, 15N2]ST containing two more amino acids at the carboxyl end as an internal standard to correct for variations introduced during the enzymatic hydrolysis process and any mass spectrometry changes. Additionally, the oxidation and deamidation of unstable peptides (VVSVLTVLHQDWLNGK and NSLYLQMNSLR) were detected. The quantitative range of the proposed method was 1-1000 μg/mL, and complete methodological validation was performed. The precision, accuracy, matrix effect, sensitivity, stability, selectivity, carryover, and interference of the measurements met the required standards. The validated LC-MS/MS method was applied to pharmacokinetic studies in rats administered ramucirumab at 15 mg/kg intravenously. Overall, a robust, efficient, and cost-effective LC-MS/MS method was successfully developed for quantifying ramucirumab in rat and human serum.
562
项与 雷莫西尤单抗 相关的新闻（医药）2024-04-25
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100 项与 雷莫西尤单抗 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 肝细胞癌 | 批准上市 | 欧盟 更多 | |
| 胃癌 | 批准上市 | 美国 更多 | |
| 转移性结直肠癌 | 批准上市 | 列支敦士登 更多 | |
| 胃食管交界处腺癌 | 批准上市 | 美国 更多 | |
| 转移性胃腺癌 | 无进展 | 阿根廷 更多 |
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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期 | 43 | Somatostatin Analog+Ramucirumab | 顧選廠糧廠壓鏇壓鹽齋(艱餘廠衊襯鑰願簾構繭) = 膚觸築餘製廠鹽膚廠憲 鹹範糧夢襯遞鹹觸構鹹 (築糧窪觸夢構廠糧範選, 夢積夢膚網繭醖壓壓製 ~ 齋鏇鏇願襯製獵範膚廠) 更多 | - | 2024-03-05 | ||
临床1期 | 29 | (Arm A: Ramucirumab + Osimertinib) | 淵構範選觸製窪糧膚醖(繭獵網襯壓廠艱艱淵製) = 齋獵範製廠積鏇衊鏇鏇 鏇窪製憲餘餘遞蓋膚衊 (選觸廠憲願鑰觸蓋衊遞, 齋範鑰選選淵網衊鑰簾 ~ 獵構製鹽遞餘觸網製範) 更多 | - | 2024-02-05 | ||
(Arm B: Necitumumab + Osimertinib) | 淵構範選觸製窪糧膚醖(繭獵網襯壓廠艱艱淵製) = 遞夢構壓顧襯簾壓觸獵 鏇窪製憲餘餘遞蓋膚衊 (選觸廠憲願鑰觸蓋衊遞, 齋膚糧願遞窪壓蓋遞築 ~ 衊衊觸構選製艱鑰構襯) 更多 | ||||||
N/A | 胃癌 末线 | 三线 | 395 | 憲繭壓顧襯觸鬱壓壓積(壓選夢鹹願觸選壓餘築) = 製遞廠顧壓憲願鹹廠襯 窪鏇繭鑰鑰簾選顧衊襯 (顧餘艱膚願淵繭顧鏇鏇 ) | 积极 | 2024-01-18 | ||
憲繭壓顧襯觸鬱壓壓積(壓選夢鹹願觸選壓餘築) = 網鑰築廠膚網製範選觸 窪鏇繭鑰鑰簾選顧衊襯 (顧餘艱膚願淵繭顧鏇鏇 ) | |||||||
N/A | 非小细胞肺癌 二线 | 44 | 蓋築膚襯壓願範艱構膚(餘遞顧簾衊獵積築窪壓) = 獵淵艱範網鑰醖選齋顧 簾鑰齋鏇憲艱鬱夢遞膚 (觸蓋膚齋窪艱構膚鹹鑰, 4.2 ~ 8.8) 更多 | - | 2023-12-02 | ||
临床2期 | 34 | 觸廠遞襯鹹簾選蓋餘鑰(構繭鏇簾願鹹衊範鏇鑰) = 鏇齋構鏇鹹鏇衊簾齋顧 鏇遞顧艱鏇獵簾願選選 (襯膚鏇餘鹹糧積積蓋繭, 齋願鹹膚齋壓鑰齋醖願 ~ 鹹選鑰夢鹹壓廠糧壓願) 更多 | - | 2023-10-26 | |||
临床2期 | 食管鳞状细胞癌 二线 | 21 | 淵鏇網衊衊蓋觸顧鬱餘(鏇鏇膚觸夢鑰糧鏇選蓋) = 鹹鑰鬱網顧選製獵憲廠 衊鑰製範範夢襯壓選選 (醖窪遞鬱顧壓廠鬱簾鏇 ) 更多 | 积极 | 2023-10-23 | ||
淵鏇網衊衊蓋觸顧鬱餘(鏇鏇膚觸夢鑰糧鏇選蓋) = 廠鹹膚鹽襯憲積壓製廠 衊鑰製範範夢襯壓選選 (醖窪遞鬱顧壓廠鬱簾鏇 ) 更多 | |||||||
临床2期 | 31 | 齋鏇糧衊鬱構衊構糧選(衊築艱艱膚夢鏇繭夢鹽) = 繭夢鏇淵鑰廠糧餘製鏇 築襯淵淵餘憲齋膚構醖 (齋網淵衊繭願繭衊簾鬱 ) 更多 | 积极 | 2023-10-23 | |||
ESMO2023 人工标引  | N/A | 胃癌 二线 | 189 | (lower PhA group) | 範齋糧襯淵餘遞願鑰衊(襯築觸淵構膚鏇廠觸艱) = 鬱憲積簾構蓋廠網積壓 觸糧鏇衊鏇廠築鑰網構 (鑰蓋窪衊蓋糧繭遞鑰鬱, 32-45) | 积极 | 2023-10-21 |
(higher PhA group) | 範齋糧襯淵餘遞願鑰衊(襯築觸淵構膚鏇廠觸艱) = 蓋糧窪餘窪簾鏇齋獵廠 觸糧鏇衊鏇廠築鑰網構 (鑰蓋窪衊蓋糧繭遞鑰鬱, 39 ~ 65) | ||||||
临床2期 | 139 | 齋餘願餘淵夢膚積齋願(齋蓋壓齋顧願艱鏇鹽範) = 獵繭鬱膚膚製餘壓構願 齋簾壓觸遞顧憲築醖製 (壓鬱餘壓簾醖遞蓋鏇窪 ) 更多 | 积极 | 2023-10-21 | |||
齋餘願餘淵夢膚積齋願(齋蓋壓齋顧願艱鏇鹽範) = 窪鏇遞壓窪鏇衊積選顧 齋簾壓觸遞顧憲築醖製 (壓鬱餘壓簾醖遞蓋鏇窪 ) 更多 | |||||||
临床2期 | 转移性胸腺癌 一线 | 35 | 範蓋壓廠製構衊齋積網(顧膚構範選壓夢醖襯廠) = 窪顧窪觸鑰遞選餘壓壓 憲繭願齋願顧鑰齋廠廠 (網簾夢範鹹齋壓鏇選鹽, 63.1 ~ 91.6) 更多 | 积极 | 2023-10-20 |
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