drugset
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
+106 more · Chinese Academy of Medical Sciences · YM BioSciences · Zhejiang University · Zhejiang Cancer Hospital · 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 · Ke Hu · 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 · all 112 on the full record

Trials 145 · 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 Stop: Enrollment
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 1/28 trials
Phase 1/2 NCT07736612 Aug 2026 → Aug 2028 expected malignant pancreatic neoplasm Zhejiang University Not yet recruiting No outcome recorded
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 Stop: Enrollment
Phase 1/2 NCT02095119 Jul 2008 → Dec 2013 cervical cancer National Institute of Cancerology Completed No outcome recorded
Phase 295 trials · 1 met primary · 2 missed
Phase 2 NCT07821242 Sep 2026 → Jun 2027 expected head and neck squamous cell carcinoma Ke Hu Not yet recruiting No outcome recorded
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 2/34 trials · 1 missed
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 Missed primary
Phase 322 trials · 1 met primary
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 NCT06343116 Apr 2024 → Apr 2027 colorectal cancer Biotech Pharmaceutical Co., Ltd. Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT06333821 Apr 2024 → Apr 2030 expected cervical 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
Comparator or background therapy8 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 2/3 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 3 NCT07706985 Comparator Jul 2026 → Jul 2030 expected nasopharyngeal carcinoma Sun Yat-sen University Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2015-05-31 Eurofarma Laboratorios S.A. Results Oncopediatras brasileiros apresentam pesquisa inédita no mais importante Congresso Mundial de Oncologia eurofarma.com.br ↗
Resultados comprovam sobrevida maior e com mais qualidade de vida em crianças com tumor raro e fatal no cérebro
2014-04-25 Daiichi Sankyo Results Daiichi Sankyo Announces Discontinuation of Phase 3 Clinical Trial in Japan of Nimotuzumab (DE-766) in Lung Cancer daiichisankyo.com ↗
The study was discontinued based on the recent recommendation of the Independent Data Monitoring Committee which observed safety issues in certain patients who received a combination of cisplatin, vinorelbine, radiotherapy, and nimotuzumab.
2009-10-15 Eurofarma Laboratorios S.A. Regulatory Câncer Infantil: Nova terapia-alvo é promissora para tratar o segundo tipo mais comum e agressivo de câncer infantil eurofarma.com.br ↗
A Agência Nacional de Vigilância Sanitária (ANVISA) acaba de aprovar a comercialização de um novo medicamento que atua como terapia-alvo.

All press releases naming this drug 5 releases

DateIssuerRelease

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 154 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 ↗
152

“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 ↗

NCT07445048 ↗

Show 142 more sources
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).” 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).” 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).” NCT01393080 ↗

“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).” 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).” NCT05316480 ↗

“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 Antibody” NCT00493857 ↗
Route Intravenous “as a 30-min infusion” PMID 28961832 ↗ Oct 2017
Target EGFR “binds to the EGFR” NCT00561990 ↗