Drugs / Nimotuzumab
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Nimotuzumab

also known as hR3 · Nimo · OSAG101 · TheraCIM h-R3 · NTZ · TheraCIM · Theraloc

Monoclonal antibody targets EGFR

Developed for
nasopharyngeal carcinoma · esophageal squamous cell carcinoma · head and neck squamous cell carcinoma · non-small cell lung carcinoma · malignant pancreatic neoplasm · cervical cancer · esophageal cancer · colorectal cancer
+37 more · carcinoma of esophagus · cervical squamous cell carcinoma · gastric cancer · gastroesophageal cancer · head and neck cancer · adenocarcinoma · cancer · cervical adenosquamous carcinoma · diffuse intrinsic pontine glioma · gastric neoplasm · oral cavity squamous cell carcinoma · pancreas disorder · adult glioblastoma · anal canal squamous cell carcinoma · bladder transitional cell carcinoma · breast cancer · cancer of unknown primary site · carcinoma · cervical carcinoma · childhood brain stem neoplasm · esophageal disorder · gastroesophageal adenocarcinoma · glioblastoma · glioma · hepatocellular carcinoma · hypopharynx squamous cell carcinoma · lung cancer · lung carcinoma · malignant glioma · neoplastic meningitis · oropharyngeal carcinoma · oropharynx squamous cell carcinoma · pancreatic ductal adenocarcinoma · pancreatic neoplasm · pancreatic neuroendocrine neoplasm · penile cancer · squamous cell carcinoma
Investigated by
Biotech Pharmaceutical Co., Ltd. · Sun Yat-sen University · Fudan University · Tianjin Medical University Cancer Institute and Hospital · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Peking University
+105 more · Chinese Academy of Medical Sciences · YM BioSciences · Zhejiang Cancer Hospital · Zhejiang University · Eurofarma Laboratorios S.A. · Fujian Cancer Hospital · The First Affiliated Hospital with Nanjing Medical University · CIMYM BioSciences · Chinese PLA General Hospital · Jiangxi Provincial Cancer Hospital · Peking Union Medical College Hospital · Peking University First Hospital · Air Force Military Medical University, China · Hangzhou Cancer Hospital · National Institute of Cancerology · Peking University Third Hospital · People's Hospital of Guangxi Zhuang Autonomous Region · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · The First Affiliated Hospital of Xiamen University · The First Affiliated Hospital of Zhengzhou University · Affiliated Cancer Hospital & Institute of Guangzhou Medical University · Affiliated Cancer Hospital of Shantou University Medical College · Affiliated Hospital of Hebei University · Baotou Cancer Hospital · Beijing Army General Hospital · Beijing Hospital · Centro de Immunologia Molecular, Cuba · Chinese Thoracic Oncology Group · Cinda Biopharmaceutical (Suzhou) Co., Ltd. · Daiichi Sankyo · Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany · Dr. Te Vuong · Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany · El Kendi Pharmaceuticals Manufacturing Company · Eye & ENT Hospital of Fudan University · First Affiliated Hospital, Sun Yat-Sen University · First People's Hospital of Foshan · Fourth Affiliated Hospital of Guangxi Medical University · Fujian Medical University Union Hospital · Fujian Province Tumor Hospital · Guangdong Association of Clinical Trials · Guangdong Provincial People's Hospital · Guangxi Medical University · Guangzhou Medical University · Guilin Medical University, China · Guiyang Medical University · Hebei Medical University Fourth Hospital · Heinrich-Heine University, Duesseldorf · Henan Cancer Hospital · Hubei Cancer Hospital · Hui Bu · Hunan Provincial Cancer Hospital · Innogene Kalbiotech Pte. Ltd · Johann Wolfgang Goethe University Hospital · Kuhnil Pharmaceutical Co., Ltd. · Laboratorios PiSA · Lei Li · Lepu Biopharma Co., Ltd. · LiuZhou People's Hospital · Ming-Yuan Chen · NanJing PLA 81 Hospital · National Cancer Centre, Singapore · National Heart Institute, Mexico · Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany · Oncoscience AG · Peking University Cancer Hospital & Institute · People's Hospital of Baise · RenJi Hospital · Roswell Park Cancer Institute · Samsung Medical Center · Second Affiliated Hospital of Guangzhou Medical University · Shandong Cancer Hospital and Institute · Shanghai Changzheng Hospital · Shanghai Chest Hospital · all 111 on the full record

Trials 143 · started per year

today
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200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT07053735 Jun 2025 → Jun 2027 expected bladder transitional cell carcinoma Peking University First Hospital Not yet recruiting No outcome recorded
Phase 1 NCT03554889 Aug 2018 → Mar 2019 cancer of unknown primary site Hangzhou Cancer Hospital Unknown No outcome recorded
Phase 1 NCT02947386 Jun 2017 → Apr 2021 non-small cell lung carcinoma Roswell Park Cancer Institute Completed No outcome recorded
Phase 1 NCT02395068 Nov 2012 → Nov 2014 cancer Biotech Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 1 NCT00985998 Sep 2009 → Aug 2015 non-small cell lung carcinoma Biotech Pharmaceutical Co., Ltd. Withdrawn No outcome recorded
Phase 1 NCT00950417 Jul 2009 → Jul 2010 esophageal cancer Biotech Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1 NCT00369252 Jun 2005 → ? YM BioSciences Completed No outcome recorded
Phase 1/27 trials
Phase 1/2 NCT07105592 May 2025 → May 2027 expected head and neck squamous cell carcinoma Fudan University Recruiting No outcome recorded
Phase 1/2 NCT06773130 Feb 2025 → Aug 2026 overdue pancreatic ductal adenocarcinoma West China Hospital Active not recruiting No outcome recorded
Phase 1/2 NCT01993784 Aug 2013 → Mar 2014 esophageal squamous cell carcinoma Peking University Unknown No outcome recorded
Phase 1/2 NCT01861223 May 2013 → May 2015 non-small cell lung carcinoma Samsung Medical Center Unknown No outcome recorded
Phase 1/2 NCT05278728 Jul 2009 → Aug 2013 colorectal cancer Biotech Pharmaceutical Co., Ltd. Completed No outcome recorded
Phase 1/2 NCT00369447 Mar 2009 → Jun 2011 non-small cell lung carcinoma YM BioSciences Terminated No outcome recorded
Phase 1/2 NCT02095119 Jul 2008 → Dec 2013 cervical cancer National Institute of Cancerology Completed No outcome recorded
Phase 294 trials
Phase 2 NCT07707973 Jul 2026 → Jan 2028 expected malignant glioma Tianjin First Central Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07601737 Apr 2026 → Apr 2028 expected head and neck squamous cell carcinoma Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Recruiting No outcome recorded
Phase 2 NCT07457528 Mar 2026 → Jun 2027 expected esophageal squamous cell carcinoma Tianjin Medical University Cancer Institute and Hospital Recruiting No outcome recorded
Phase 2 NCT07446270 Mar 2026 → Oct 2027 expected colorectal cancer Chinese PLA General Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07240766 Feb 2026 → May 2027 expected adenocarcinoma Zhejiang University Recruiting No outcome recorded
Phase 2 NCT07310771 Jan 2026 → Jul 2027 expected head and neck squamous cell carcinoma Fujian Cancer Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07354984 Jan 2026 → Dec 2029 expected head and neck squamous cell carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07277452 Dec 2025 → Dec 2028 expected malignant pancreatic neoplasm The First Affiliated Hospital with Nanjing Medical University Not yet recruiting No outcome recorded
Phase 2 NCT07386704 Dec 2025 → Dec 2026 expected malignant pancreatic neoplasm Peking University First Hospital Enrolling by invitation No outcome recorded
Phase 2 NCT07353723 Nov 2025 → Nov 2026 expected head and neck cancer Tang-Du Hospital Recruiting No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT06409429 May 2024 → May 2027 expected malignant pancreatic neoplasm Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
Phase 2/3 NCT02272699 Nov 2014 → Dec 2020 esophageal squamous cell carcinoma Peking University Withdrawn No outcome recorded
Phase 2/3 NCT01402180 Dec 2010 → Dec 2013 esophageal squamous cell carcinoma Fudan University Unknown No outcome recorded
Phase 2/3 NCT01249352 Jan 2009 → Nov 2013 adenocarcinoma, esophageal cancer Eurofarma Laboratorios S.A. Completed No outcome recorded
Phase 322 trials
Phase 3 NCT07445048 Mar 2026 → Mar 2028 expected head and neck squamous cell carcinoma Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Recruiting No outcome recorded
Phase 3 NCT07333274 Jan 2026 → Jan 2028 expected head and neck squamous cell carcinoma Shandong Cancer Hospital and Institute Recruiting No outcome recorded
Phase 3 NCT05978050 Aug 2024 → Mar 2026 overdue gastroesophageal adenocarcinoma Biotech Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06333821 Apr 2024 → Apr 2030 expected cervical cancer Biotech Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06343116 Apr 2024 → Apr 2027 expected colorectal cancer Biotech Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06026878 Sep 2023 → Sep 2025 overdue nasopharyngeal carcinoma Air Force Military Medical University, China Recruiting No outcome recorded
Phase 3 NCT05772208 Jan 2022 → Jan 2025 overdue nasopharyngeal carcinoma Fudan University Recruiting No outcome recorded
Phase 3 NCT04532229 Apr 2021 → Oct 2023 diffuse intrinsic pontine glioma Biotech Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase 3 NCT04456322 Aug 2020 → May 2024 overdue nasopharyngeal carcinoma Sun Yat-sen University Active not recruiting No outcome recorded
Phase 3 NCT03837808 Apr 2019 → Feb 2024 nasopharyngeal carcinoma Sun Yat-sen University Unknown No outcome recorded
Phase 43 trials
Phase 4 NCT06879691 May 2021 → Apr 2025 overdue head and neck cancer Biotech Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 4 NCT02945267 Sep 2016 → Dec 2018 pancreas disorder Chinese PLA General Hospital Unknown No outcome recorded
Phase 4 NCT02293356 Aug 2015 → Dec 2017 nasopharyngeal carcinoma Biotech Pharmaceutical Co., Ltd. Unknown No outcome recorded
Phase not applicable6 trials
NCT07388095 Feb 2026 → Feb 2027 expected esophageal squamous cell carcinoma Tianjin Medical University Cancer Institute and Hospital Not yet recruiting No outcome recorded
NCT06022276 Dec 2022 → Dec 2024 cancer Tianjin Medical University Second Hospital Unknown No outcome recorded
NCT05717790 Dec 2022 → Nov 2024 overdue nasopharyngeal carcinoma Fourth Affiliated Hospital of Guangxi Medical University Recruiting No outcome recorded
NCT04678791 Dec 2020 → Dec 2024 cervical squamous cell carcinoma Peking University Third Hospital Unknown No outcome recorded
NCT01393080 Mar 2011 → Dec 2016 non-small cell lung carcinoma Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded
NCT02549261 Mar 2011 → Apr 2012 non-small cell lung carcinoma Biotech Pharmaceutical Co., Ltd. Unknown No outcome recorded
Also used as a comparator or background therapy in 8 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT05355168 Background Nov 2021 → Dec 2023 poisoning Anhui Provincial Hospital Completed No outcome recorded
Phase 2 NCT03620032 Background Nov 2015 → Nov 2022 diffuse intrinsic pontine glioma Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Unknown No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT07535567 Comparator May 2026 → Dec 2028 expected head and neck squamous cell carcinoma Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Not yet recruiting No outcome recorded
Phase 2/3 NCT00561990 Comparator Sep 2007 → Jan 2013 malignant pancreatic neoplasm Oncoscience AG Completed No outcome recorded
Phase 34 trials
Phase 3 NCT07706985 Comparator Jul 2026 → Jul 2030 expected nasopharyngeal carcinoma Sun Yat-sen University Recruiting No outcome recorded
Phase 3 NCT06561763 Background Aug 2024 → Aug 2028 expected nasopharyngeal carcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 3 NCT02409186 Comparator Mar 2015 → Dec 2017 Shandong Cancer Hospital and Institute Unknown No outcome recorded
Phase 3 NCT00957086 Comparator Aug 2009 → Jan 2025 head and neck squamous cell carcinoma National Cancer Centre, Singapore Unknown No outcome recorded

Press releases naming this drug 3 releases

DateIssuerRelease
2014-04-25 Daiichi Sankyo Daiichi Sankyo Announces Discontinuation of Phase 3 Clinical Trial in Japan of Nimotuzumab (DE-766) in Lung Cancer daiichisankyo.com
2013-04-25 Daiichi Sankyo Daiichi Sankyo Enrolls First Patient in Nimotuzumab Phase 3 Clinical Trials daiichisankyo.com
2006-08-01 Daiichi Sankyo Daiichi Pharmaceutical to Develop and Market Anti-EGFr Drug Nimotuzumab in Japan daiichisankyo.com

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 152 sources stand behind the page.

FieldValueCited text
Known as Nimotuzumab Nimotuzumab is a humanized monoclonal antibody that can competitively inhibit the binding of endogenous ligands to EGFR, block the downstream signal transduction pathway...” NCT05508347
150

“This study aims to preliminarily explore the efficacy and safety of Iparomlimab and Tuvonralimab in combination with Nimotuzumab for the treatment of recurrent/metastatic...” NCT07101744

“Cetuximab 400mg/m2 will be used one week before radiotherapy and 250mg/m2/week during IMRT, or nimotuzumab 200mg/week; meanwhile, cisplatin 80mg/m2 will be used every 3 weeks.” NCT04508829

Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT01425736

“The participants will receive Toripalimab 240mg intravenous infusion every 3 week, and Nimotuzumab 150mg/㎡ every 2 week for 2 cycles” NCT05803915

“Toripalimab Combined With Nimotuzumab Induction therapy then surgery and Toripalimab Combined With Nimotuzumab adjuvant Therapy” NCT06912711

“Drug: Nimotuzumab Nimotuzumab: 400mg iv on Day 1 of cycle, every week, until disease progression” NCT04136600

“[Docetaxel 75mg/m2 + Nimotuzumab 400mg + Pucotenlimab 200mg]” NCT07354984

Nimotuzumab is a EGFR monoclonal antibody.” NCT06022276

Nimotuzumab:400 mg” NCT07388095

NCT06718205

NCT02395068

NCT07457528

NCT06389760

NCT07310771

NCT06509009

NCT06333821

NCT01393080

NCT04508816

NCT02945267

NCT00972465

NCT00753246

NCT04882462

NCT06429839

NCT07445048

NCT02672241

NCT02293356

NCT06676722

NCT06429904

NCT03574402

NCT07053735

NCT00561990

NCT02011594

NCT06422156

NCT01393184

NCT07240766

NCT03413579

NCT03766178

NCT01180166

NCT04678791

NCT04821843

NCT01993784

NCT02034968

NCT01498562

NCT06413017

NCT07070479

NCT06048913

NCT00985998

NCT04223024

NCT05316480

NCT01345084

NCT06343116

NCT03620032

NCT01145170

NCT02041819

NCT01486992

NCT01336049

NCT04456322

NCT07706985

NCT01899118

NCT02039791

NCT02012062

NCT06770452

NCT02370849

NCT02591784

NCT07707973

NCT05717790

NCT06404840

NCT00957086

NCT03666221

NCT06879691

NCT00369252

NCT05606263

NCT00600054

NCT00872482

NCT06259721

NCT04821778

NCT01301612

NCT01382745

NCT02083211

NCT06409429

NCT07386704

NCT03837808

NCT03915132

NCT02395016

NCT03557112

NCT05772208

NCT03708822

NCT07333274

NCT01616849

NCT02858206

NCT05351762

NCT01516996

NCT01463605

NCT07277452

NCT06410651

NCT04664244

NCT00702481

NCT02549261

NCT07446270

NCT02272699

NCT01861223

NCT01074021

NCT05278728

NCT00369447

NCT06561763

NCT00493857

NCT05355168

NCT01402180

NCT06773130

NCT05024019

NCT01939054

NCT00910117

NCT02947386

NCT05978050

NCT04532229

NCT03388372

NCT06938503

NCT04833205

NCT03469531

NCT03554889

NCT07105592

NCT04367909

NCT01232374

NCT04475016

NCT07312578

NCT06490341

NCT03025958

NCT07535567

NCT02409186

NCT06771596

NCT01688700

NCT06781073

NCT00950417

NCT00983047

NCT04207918

NCT02428764

NCT01249352

NCT02705612

NCT07353723

NCT03400592

NCT06405685

NCT02577341

NCT07601737

NCT06988956

NCT02095119

NCT01813253

NCT06722911

NCT06039891

NCT06026878

NCT02611700

Known as hR3 “Drug: Nimotuzumab Concurrent radiochemotherapy period, 150mg/m2, weekly, for 6 weeks; Maintenance period, from the 7th to the 52nd week, 150mg/m2, every two weeks until disease...” NCT04532229
10

“Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT00985998

“Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT00950417

“Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT05316480

“Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT02549261

“Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT02591784

“Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT01393080

“Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR).” NCT01425736

“mAb Nimotuzumab hR3 will be administered endovenously in a 250 mL saline solution in 30 min. infusion ambulatory.” NCT02083211

“Nimotuzumab (OSAG101, hR3, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR.” NCT00561990

“Nimotuzumab ( h-R3)” NCT03413579

Known as Nimo “of which 56 patients were added with Nimotuzumab (Nimo) and were divided into three groups” NCT05508347
2

Nimotuzumab (Nimo): Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT” NCT01393184

nimotuzumab (nimo) will be administered” NCT06389760

Known as NTZ “cetuximab (CTX) or nimotuzumab (NTZ)” NCT04508816
Known as OSAG101 “Patients randomly assigned to arm A will receive Nimotuzumab (OSAG 101) plus Temozolomide concomitant with standard radiotherapy.” NCT00753246
1

“Nimotuzumab (OSAG101, hR3, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR.” NCT00561990

Known as TheraCIM “Phase 2 Study of Safety and Efficacy of Nimotuzumab (TheraCIM®) in Pediatric Patients With Recurrent Diffuse Intrinsic Pontine Glioma” NCT00600054
Known as TheraCIM h-R3 “This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer.” NCT00369447
1

“Nimotuzumab (TheraCIM h-R3)” NCT00369252

Known as Theraloc “Nimotuzumab (OSAG101, hR3, Theraloc) is a humanized monoclonal antibody (mAb) that binds to the EGFR.” NCT00561990
Action Inhibit “EGFR inhibition using Nimotuzumab” NCT00702481
Modality Monoclonal antibody “Nimotuzumab Humanized Monoclonal AntibodyNCT00493857
Route Intravenous “as a 30-min infusion” PMID 28961832 Oct 2017
Target EGFR “binds to the EGFRNCT00561990