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更新于：2026-10-22
Nimotuzumab
尼妥珠单抗
更新于：2026-10-22
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 印度 (2006-09-11), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (欧盟) |
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结构/序列
Sequence Code 9615890L
来源: *****
Sequence Code 1191632866H
来源: *****
关联
253
项与 尼妥珠单抗 相关的临床试验NCT07821242
A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined With Radiotherapy for Elderly Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
NCT07736612
A Phase Ib/II Study of the Safety, Tolerability, and Efficacy of a Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer
ChiCTR2600128718
A Prospective, Single-Arm, Phase II Clinical Study of Nimotuzumab Combined with Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Oral Squamous Cell Carcinoma
100 项与 尼妥珠单抗 相关的临床结果
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100 项与 尼妥珠单抗 相关的转化医学
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100 项与 尼妥珠单抗 相关的专利（医药）
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373
项与 尼妥珠单抗 相关的文献（医药）2026-11-01INTERNATIONAL JOURNAL OF CANCER
Nimotuzumab Combined With Concurrent Curative Radiotherapy and S‐1 in 75 Years and Older Patients With Stage
II
‐
IVB
Esophageal Squamous Cell Carcinoma: A Phase
II
Study
Article
作者: Ge, Xiaolin ; Sun, Xinchen ; Chen, Hui ; Xia, Xiaojie ; Xu, Lu ; Yan, Jingze
ABSTRACT:
Concurrent chemoradiotherapy is the standard treatment for inoperable, locally advanced esophageal cancer. However, older patients often have reduced tolerance to radiotherapy and concurrent intravenous chemotherapy due to declining physical function and multiple comorbidities. This prospective, single‐center, phase II study assessed the efficacy and safety of nimotuzumab, an epidermal growth factor receptor antagonist, combined with concurrent radiotherapy and S‐1 in patients 75 years and older. A total of 56 patients were enrolled, with the primary endpoint being progression‐free survival (PFS), while secondary endpoints included overall survival (OS), objective response rate, disease control rate, treatment‐related adverse events, nutritional indicators, and quality of life (QOL). Most nutritional indicators remained stable after treatment. As of June 2024, the median follow‐up duration was 24.1 months (8.8–34.1). Eleven patients achieved complete response, 39 achieved partial response, five had stable disease, and one experienced progressive disease. The median PFS was 25.3 months (95% CI, 16.5–34.1), while the median OS was 28.2 months (95% CI, 24.1–32.3). Most adverse events were grade 1–2 (85.7%). Among survivors, 45.5% reported high satisfaction with their QOL, and 84.8% did not experience weight loss. This combination therapy demonstrated promising efficacy and safety, suggesting it may be a viable treatment option for this patient population.
2026-10-01Clinical Pharmacology in Drug Development
A Phase I Study of Nimotuzumab Combined with Irinotecan in Chinese Patients with Advanced Solid Tumors
Article
作者: Jiang, Zhichao ; Du, Chunxia ; Sun, Yongkun ; Zhou, Aiping ; Zhang, Wen
Abstract:
Nimotuzumab is an anti‐epidermal growth factor receptor antibody. This Phase I study evaluated the pharmacokinetics and safety of nimotuzumab plus irinotecan in Chinese patients with advanced solid tumors. At single ascending dosage (SAD) stage, four cohorts (100, 200, 400, and 600 mg) of patients received nimotuzumab intravenously on Day 1, alongside irinotecan 180 mg/m
2
on Day 8. Three weeks later, all patients in the four cohorts transferred to multiple ascending dosage (MAD) stage: nimotuzumab was administrated weekly for 6 weeks, alongside irinotecan (Days 1, 15, 29, 43, and 57, 180 mg/m
2
). Primary objective was pharmacokinetics, safety and tolerability was also examined. From December 2012 to October 2014, in SAD and MAD stages, there were 28 and 39 patients with Stage IV solid tumors. The area under the concentration curve (AUC
0–∞
) for a single dose of nimotuzumab was 10.2 ± 2.7 (100 mg), 37.6 ± 10.0 (200 mg), 114.8 ± 35.5 (400 mg), 197.6 ± 32.0 (600 mg) (×100 h µg/mL), and for multiple dose, it was 26.7 ± 3.4 (100 mg), 87.1 ± 12.0 (200 mg), 193.4 ± 46.9 (400 mg) and 446.3 ± 100.7 (600 mg) (×100 h µg/mL). There was low incidence of rash and no dose‐limiting toxicities occurred. This study indicated that nimotuzumab at doses ranging from 100 to 600 mg exhibited a manageable and tolerable safety profile.
2026-09-01EClinicalMedicine
Efficacy and safety of liposomal irinotecan plus nimotuzumab in immune checkpoint inhibitor-refractory recurrent or metastatic nasopharyngeal carcinoma: a single-arm, open-label, phase II trial
Article
作者: Wang, Lin ; He, Shuiqing ; Tang, Linquan ; Chen, Chunyan ; Ye, Yanfang ; Bei, Wei-Xin ; Zhao, Ze-Yu ; Lv, Shuhui ; Lu, Nian ; Xiang, Yan-Qun ; Liu, Liting
Background:
Patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) who progress after immune checkpoint inhibitor (ICI) therapy have limited treatment options and poor outcomes. We evaluated the efficacy and safety of liposomal irinotecan plus nimotuzumab in patients with epidermal growth factor receptor (EGFR)-positive, ICI-refractory R/M NPC.
Methods:
In this single-arm, open-label, phase II trial (NCT06414577) conducted in China, patients with EGFR-positive, ICI-refractory R/M NPC were enrolled between May 27, 2024, and January 9, 2025. Patients received intravenous liposomal irinotecan (70 mg/m2) plus nimotuzumab (400 mg) every 2 weeks for up to eight cycles. The primary endpoint was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1.
Findings:
Thirty-six heavily pretreated patients were enrolled, of whom 12 (33.3%) had received three or more prior lines of therapy for advanced disease. In the intention-to-treat population, 13 of 36 patients achieved an objective response (ORR 36.1%; 95% CI 20.8-53.8), and 22 of 36 patients achieved disease control (61.1%). Median progression-free survival was 3.0 months (95% CI, 2.2-4.1), and median duration of response was 2.3 months (95% CI 1.5-3.1). After a median follow-up of 22.0 months, the median overall survival was 14.1 months (95% CI, 8.7-not estimable). Grade 3 or higher treatment-related adverse events occurred in eight of 36 patients (22.2%), and no treatment-related deaths were observed. In a post-hoc exploratory analysis, an early decline of at least 50% in plasma Epstein-Barr virus DNA was associated with a higher ORR.
Interpretation:
Liposomal irinotecan plus nimotuzumab showed preliminary antitumor activity and manageable safety in heavily pretreated patients with ICI-refractory R/M NPC. However, response durability was limited, and further comparative studies are needed to evaluate its clinical value and identify patients most likely to derive durable benefit.
Funding:
Supported by grants from the National Natural Science Foundation of China, Science and Technology Program of Guangdong Esophageal Cancer Institute, and China Postdoctoral Science Foundation.
100 项与 尼妥珠单抗 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 |
|---|---|---|---|
| 胰腺癌 | 中国 | 2023-06-07 | |
| 头颈部鳞状细胞癌 | 印尼 | 2022-10-19 | |
| 鼻咽癌 | 中国 | 2008-01-07 | |
| 胶质瘤 | 乌克兰 | 2007-10-10 | |
| 头颈部肿瘤 | 印度 | 2006-09-11 |
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 |
|---|---|---|---|---|
| 胃食管交界处腺癌 | 临床3期 | 中国 | 2024-08-01 | |
| 胃食管交界处癌 | 临床3期 | 中国 | 2024-08-01 | |
| 胃腺癌 | 临床3期 | 中国 | 2024-08-01 | |
| 转移性结直肠癌 | 临床3期 | - | 2024-04-03 | |
| 晚期头颈部鳞状细胞癌 | 临床3期 | 中国 | 2021-11-01 | |
| 弥漫内生性脑桥神经胶质瘤 | 临床3期 | 中国 | 2021-04-03 | |
| 宫颈鳞状细胞癌 | 临床3期 | 中国 | 2016-05-10 | |
| 食管鳞状细胞癌 | 临床3期 | 中国 | 2015-11-13 | |
| 转移性食管鳞状细胞癌 | 临床3期 | 中国 | 2015-11-01 | |
| 宫颈癌 | 临床3期 | 阿尔及利亚 | - | 2015-10-28 |
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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 | 60 | 壓願觸積網蓋鹽齋鹹壓(糧衊窪鑰範築顧蓋網築) = 鑰願獵鑰衊範鑰蓋壓醖 獵遞範醖衊願鑰鹽遞鏇 (製鹽餘衊艱鬱蓋願壓範, 69 ~ 89) 更多 | 积极 | 2026-10-23 | |||
临床2期 | 胰腺癌 辅助 | 52 | Nimotuzumab plus mFOLFIRINOX | 鹹範鏇醖廠廠餘鏇餘蓋(淵蓋繭餘鑰鹽糧鏇製餘) = 鏇餘鏇窪鑰餘蓋壓願糧 簾願蓋鑰簾獵襯築願壓 (衊獵觸繭築製壓衊築繭 ) 更多 | 积极 | 2026-10-23 | |
Nimotuzumab plus gemcitabine+capecitabine | 壓積餘壓衊鏇獵淵蓋觸(齋遞膚簾鑰廠範襯遞衊) = 繭廠構選繭獵襯簾鏇選 鑰鹽壓醖範鹽簾繭蓋鹽 (夢憲夢憲顧糧遞遞範襯 ) | ||||||
N/A | - | 12 | Radiotherapy + Nimotuzumab/Vinorelbine regimen (NV) | 築餘夢構築範範衊餘襯(選積鹹憲鏇獵淵鏇廠鏇) = 憲積齋餘糧艱夢製壓膚 範醖衊積觸糧蓋鬱餘鑰 (膚網蓋選蓋願醖憲醖鹹, 0 ~ 43) 更多 | 不佳 | 2026-09-24 | |
临床2期 | 46 | 醖鬱蓋製衊獵窪艱範襯(鹹淵憲範鏇鬱觸鏇鑰遞) = 窪構觸蓋鹽淵膚鬱範淵 鬱顧顧襯鑰觸觸壓糧積 (鬱遞鹽醖構繭壓鹽鏇鏇, 19.5 ~ 48.0) 更多 | 积极 | 2026-09-01 | |||
醖鬱蓋製衊獵窪艱範襯(鹹淵憲範鏇鬱觸鏇鑰遞) = 淵鏇鬱鹹鬱蓋艱膚鹽蓋 鬱顧顧襯鑰觸觸壓糧積 (鬱遞鹽醖構繭壓鹽鏇鏇 ) | |||||||
临床2期 | 扁桃体肿瘤 新辅助 | 20 | 遞壓製鏇壓窪鑰鬱鬱鏇(鏇襯壓築獵醖鑰願蓋夢) = 築觸餘憲願夢壓鹹廠構 積壓簾構顧網鏇膚觸艱 (構窪襯製製襯簾鬱齋製 ) 更多 | 积极 | 2026-07-14 | ||
临床3期 | 172 | Nimotuzumab plus standard therapy (Stage III-IVa nasopharyngeal carcinoma) | 觸築築齋繭膚網簾糧醖(築膚齋醖衊範鹹餘衊壓) = 構襯鏇壓積廠膚憲餘憲 願築遞範夢製願憲鬱淵 (齋選願廠廠齋蓋獵鹽範 ) 更多 | 积极 | 2026-06-25 | ||
Standard therapy (Stage III-IVa nasopharyngeal carcinoma) | 觸築築齋繭膚網簾糧醖(築膚齋醖衊範鹹餘衊壓) = 醖餘糧糧餘製製壓糧蓋 願築遞範夢製願憲鬱淵 (齋選願廠廠齋蓋獵鹽範 ) 更多 | ||||||
临床2期 | 阴茎鳞状细胞癌 新辅助 | 29 | 鏇積齋夢鬱繭鏇網糧繭(顧築膚積鑰蓋獵蓋觸衊) = 齋齋衊襯觸壓餘選壓鏇 鹽遞膚壓夢糧餘齋襯夢 (簾憲衊顧獵齋築積觸鹹, 54.1 ~ 88.2) 更多 | 积极 | 2026-06-25 | ||
(non-pCR group) | 選積顧構鏇淵廠鏇廠膚(膚鏇襯廠蓋簾糧壓餘構) = 夢憲顧願鹹顧襯襯顧鬱 壓憲製憲網願簾淵淵鹹 (構醖夢淵衊膚夢膚餘窪, 12 ~ NR) 更多 | ||||||
N/A | 108 | 襯襯糧簾窪網範製範鏇(衊衊膚選壓衊廠淵鹽廠) = Toxicity was grade 2 and 3 in both group some patient only grade 4 toxicity in both arm 襯夢繭襯衊鏇鹽夢襯鏇 (齋醖鏇築醖糧夢網夢齋 ) | 积极 | 2026-06-25 | |||
N/A | 497 | 簾鹹觸範淵餘蓋夢憲糧(糧蓋鬱襯廠簾積選衊憲) = 鬱餘繭獵構廠壓鏇鏇淵 醖鏇齋夢衊網製淵遞襯 (簾窪遞繭範餘構淵蓋淵 ) 更多 | 积极 | 2026-05-29 | |||
簾鹹觸範淵餘蓋夢憲糧(糧蓋鬱襯廠簾積選衊憲) = 鹽繭齋願鹽齋蓋廠獵鏇 醖鏇齋夢衊網製淵遞襯 (簾窪遞繭範餘構淵蓋淵 ) 更多 | |||||||
临床2期 | 56 | Nimotuzumab plus S-1 and concurrent radiotherapy | 淵遞製獵構壓窪憲鹽鹽(憲遞膚製衊齋構鬱齋餘) = 構壓糧簾襯構鬱餘顧遞 憲壓壓夢範願觸遞鹽憲 (繭壓膚鬱艱醖壓糧糧遞, 55.5 ~ 80.1) 更多 | 积极 | 2026-05-29 |
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