YM BioSciences :: Products :: Nimotuzumab

Clinical Trials

Nimotuzumab is currently being studied in clinical trials around the world in multiple indications including non-small cell lung cancer, pediatric and adult glioma, esophageal cancer, pancreatic cancer, gastric cancer and head & neck cancer. Nimotuzumab has been approved for marketing in 23 countries including Brazil, India, China, Argentina and Indonesia.

For details about clinical trials with nimotuzumab, move your mouse over the indications below.

Nimotuzumab - Global Clinical Development - YM BioSciences and Licensees

Indication	Phase I	Phase II	Phase III	Publications
Pediatric Diffuse Intrinsic Pontine Glioma first line [nimotuzumab + radiotherapy] Study Design: multi-center, prospective, non-randomized, non-blinded, open-label, single-arm Primary Endpoint: progression-free survival at 6, 12 and 18 months Secondary Endpoints: objective response; toxicity profile; duration of response; overall survival Dose: 150mg/m² # Patients: 42 (enrollment complete) Trial Location: Germany Lead Sponsor: Oncoscience AG
Adult Glioma first line [temozolomide + radiotherapy +/- nimotuzumab] Study Design: multi-center, prospective, randomized, two-arm Primary Endpoint: progression-free survival at 6, 12 and 18 months Secondary Endpoints: overall survival; response rate; time-to-reintervention; toxicity; symptoms control Dose: 400mg # Patients: 148 (enrollment ongoing) Trial Location: Germany Lead Sponsor: Oncoscience AG
Squamous Cell Carcinoma of the Head & Neck adjuvant [radiotherapy + cisplatin +/- nimotuzumab] Primary Endpoint: DFS at w years and 5 years Secondary Endpoints: overall survival at 2 years and 5 years; toxicity Dose: 200mg # Patients: 710 (enrollment ongoing) Trial Location: Singapore Lead Sponsor: National Cancer Centre Singapore, Innogene Kalbiotech
Pancreatic Cancer first line [gemcitabine +/- nimotuzumab] Study Design: randomized, controlled, double-blind Primary Endpoints: time-to-progression; overall survival Secondary Endpoints: overall response rate; duration of response; safety profile; quality of life Dose: 400mg # Patients: 188 (enrollment ongoing) Trial Location: Germany Lead Sponsor: Oncoscience AG
Head & Neck Cancer first line [nimotuzumab + radiotherapy] Study completed Trial Location: Canada Lead Sponsor: YM BioSciences
Pediatric Glioma (high grade) recurrent [monotherapy] Study completed Primary Endpoint: response rate Secondary Endpoints: progression-free survival; survival; toxicity; symptoms control; PK analysis Dose: 150mg/m² # Patients: 47 Trial Location: Germany Lead Sponsor: Oncoscience AG
Pancreatic Cancer advanced refractory [monotherapy] Study completed Primary Endpoint: response rate Secondary Endpoints: survival benefit; time-to-disease progression Dose: 100/200/400/600/800mg # Patients: 65 Trial Location: Europe Lead Sponsor: Oncoscience AG
Colorectal Cancer irinotecan refractory [nimotuzumab + irinotecan] Study closed Study Design: non-randomized, open-label, active control, two-cohort Primary Endpoint: objective response rate Secondary Endpoints: overall survival; response rate; duration of response; progression-free survival Dose: 400mg # Patients: 61 Trial Location: Canada Lead Sponsor: YM BioSciences
Non-Small Cell Lung Cancer (palliative) first line or later [radiotherapy +/- nimotuzumab] Study Design: randomized, double-blind Primary Endpoint: overall survival Secondary Endpoints: progression-free survival; time-to-progression; time-to-local progression; overall response rate; local response rate; overall clinical benefit; safety; quality of life Dose: 200mg # Patients: 128 (enrollment ongoing) Trial Location: Canada Lead Sponsor: YM BioSciences
Brain Metastasis from Non-Small Cell Lung Cancer first line or later [whole-brain radiation +/- nimotuzumab] Study Design: randomized, double-blind Primary Endpoint: intracranial disease progression at 6 months Secondary Endpoints: overall survival; time-to-neurological progression; overall survival rate at 6 months; time-to-intracranial disease progression; time-to-overall progression Dose: 200mg # Patients: 88 (enrollment ongoing) Trial Location: Canada Lead Sponsor: YM BioSciences
Non-Small Cell Lung Cancer [nimotuzumab + radiotherapy + cisplatin + vinorelbine] Primary Endpoint: rate of completed concurrent chemoradiation Secondary Endpoints: safety; response rate; DCR; progression-free survival; overall survival; pharmacokinetics; HAHA Dose: 200mg # Patients: 39 (enrollment ongoing) Trial Location: Japan Lead Sponsor: Daiichi-Sankyo
Pediatric Diffuse Intrinsic Pontine Glioma recurrent [monotherapy] Study Design: multi-center, prospective, open-label, single-arm Primary Endpoints: objective response rate; safety profile Secondary Endpoints: overall survival; clinical benefit; response rate at week 18; duration of response; time-to-progression; symptom control Dose: 150mg/m² # Patients: 42 (enrollment ongoing) Trial Locations: Canada, US Lead Sponsor: YM BioSciences
Pediatric Brain Stem Tumors (Expanded Access ) recurrent [monotherapy] Expanded Access Program Trial Location: USA Lead Sponsor: YM BioSciences
Squamous Cell Carcinoma of the Head & Neck locally advanced [nimotuzumab + cisplatin + radiotherapy] Primary Endpoint: response rate Secondary Endpoints: progression-free survival; toxicity Dose: 200mg # Patients: 37 (enrollment ongoing) Trial Location: Singapore Lead Sponsor: National Cancer Centre Singapore, Innogene Kalbiotech
Gastric Cancer advanced/recurrent, 5-FU refractory [irinotecan +/- nimotuzumab] Primary Endpoint: progression-free survival Secondary Endpoints: response rate; DCR; duration of response; time-to-progression; TTF; overall survival; safety; PK with CPT-1; HAHA; biomarkers Dose: 400mg # Patients: 80 (enrollment ongoing) Trial Locations: Japan, Korea Lead Sponsors: Daiichi-Sankyo and Kuhnil Pharma
Cervical Cancer [nimotuzumab + radiotherapy] Primary Endpoints: feasibility; safety and efficacy Secondary Endpoints: tumor response; time-to-progression; survival rate at 2 years Dose: 200mg # Patients: 71 (enrollment ongoing) Trial Location: Indonesia Lead Sponsor: Innogene Kalbiotech
Non-Small Cell Lung Cancer first line [radiotherapy +/- nimotuzumab] Study complete Study Design: dose escalation study, open-label, uncontrolled Primary Endpoints: safety and feasibility Secondary Endpoint: optimal biological dose Dose: 100/200/400mg # Patients: 34 (enrollment complete) Trial Locations: Canada, Korea Lead Sponsors: YM BioSciences and Kuhnil Pharma
Japanese Safety Study refractory solid tumors [monotherapy] Study completed Study Design: dose escalation study, single-center, open-label Primary Endpoints: safety profile; pharmacokinetics Secondary Endpoints: immunogenicity; anti-tumor response; pharmacodynamics Dose: 100/200/400mg # Patients: 13 Trial Location: Japan Lead Sponsor: Daiichi-Sankyo
Pharmacodynamic Study refractory solid tumors [monotherapy] Study completed Study Design: dose escalation and pharmacodynamic study, open-label Primary Endpoints: safety and tolerability Secondary Endpoint: pharmacodynamics Dose: 100/200/400/800mg # Patients: 17 Trial Location: Canada Lead Sponsor: YM BioSciences

completed study

ongoing study

multi-phase study

Nimotuzumab - Global Clinical Development - CIMYM BioSciences and Licensees

Indication	Phase I	Phase II	Phase III	Publications
Squamous Cell Carcinoma of the Head & Neck stage III/IV [radiotherapy +/- chemotherapy +/- nimotuzumab] Primary Endpoints: safety and tolerability; efficacy Secondary Endpoint: overall survival Dose: 200mg # Patients: 150 (enrollment ongoing) Trial Location: India Lead Sponsor: Biocon
Cervical Cancer [cisplatin + vinorelbine +/- nimotuzumab] # Patients: 168 (enrollment ongoing) Trial Location: Mexico Lead Sponsor: Laboratorios PiSA
Adult Glioma (placebo) first line [radiotherapy +/- nimotuzumab] Study Design: multi-center, controlled, double-blind, randomized, stratified, parallel groups Primary Endpoint: survival benefit Secondary Endpoints: progression-free survival; toxicity; prognostic value of EGFR expression Dose: 200mg # Patients: 80 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Adult Glioma (open label) first line [nimotuzumab + temozolomide + radiotherapy] Study Design: prospective, open-label, single-arm Primary Endpoint: overall survival Secondary Endpoints: progression-free survival; tumor response; safety and tolerability Dose: 200mg # Patients: 56 (enrollment ongoing) Trial Location: India Lead Sponsor: Biocon
Head & Neck Cancer locally advanced [radiotherapy +/- chemotherapy +/- nimotuzumab] Study completed Primary Endpoint: safety and efficacy Secondary Endpoints: progression-free survival; tumor response; duration of tumor response Dose: 200mg # Patients: 92 Trial Location: India Lead Sponsor: BBPL
Head & Neck Cancer nasopharyngeal [radiotherapy +/- nimotuzumab] Study completed; Approved in China Primary Endpoints: safety and tolerability; complete response rate Secondary Endpoints: duration of response; incidence of adverse events Dose: 100mg # Patients: 137 Trial Location: China Lead Sponsor: Biotech Pharma
Adult Glioma (open label) first line [nimotuzumab + radiotherapy] Study completed Primary Endpoint: survival Secondary Endpoints: safety and tolerability; response rate; immunogenicity Dose: 200mg # Patients: 29 Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Pediatric Brain Stem Tumors [monotherapy] # Patients: 42 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Centre of Molecular Immunology (CIM)
Non-Small Cell Lung Cancer stage IIIb/IV, first line [nimotuzumab + docetaxel + carboplatin] Primary Endpoint: objective response rate Secondary Endpoints: overall survival; progression-free survival; toxicity Dose: 200mg # Patients: 110 (enrollment ongoing) Trial Location: India Lead Sponsor: Biocon
Brain Metastasis from Non-Small Cell Lung Cancer [radiotherapy +/- nimotuzumab] Study Design: controlled, randomized Primary Endpoint: disease control Secondary Endpoints: survival; objective response; duration of disease control; toxicity; quality of life Dose: 200mg # Patients: 30 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Hormone-Refractory Prostate Cancer first line [mitoxantrone + prednisone +/- nimotuzumab] Study Design: multi-center, randomized, controlled, open-label Primary Endpoint: survival benefit Secondary Endpoints: time-to-progression; response rate; toxicity; immunogenicity; quality of life Dose: 200mg # Patients: 70 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Esophageal Cancer first line [radiotherapy + cisplatin + 5-FU +/- nimotuzumab] Study Design: multi-center, controlled, randomized, open-label Primary Endpoint: objective tumor response Secondary Endpoints: duration of response; toxicity; immunogenicity; quality of life Dose: 200mg # Patients: 68 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Esophageal Cancer first line [radiotherapy + chemotherapy +/- nimotuzumab] Primary Endpoint: overall survival Secondary Endpoints: time-to-progression; complete response rate; endoscopic complete response rate; resectability rate; quality of life Dose: 200mg # Patients: 104 (enrollment ongoing) Trial Location: Brazil Lead Sponsor: Eurofarma
Anal Cancer [radiotherapy + chemotherapy +/- nimotuzumab] # Patients: 160 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Centre of Molecular Immunology (CIM)
Hepatic Metastasis from Colon Cancer [nimotuzumab + 5-FU + lipidol] Primary Endpoint: toxicity Secondary Endpoints: maximum tolerated dose or optimal biological dose; overall survival; response rate Dose: 50/100/200/400mg # Patients: 15 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Breast Cancer adjuvant, first line [nimotuzumab + doxorubicin + cyclophosphamide] Study completed Study Design: dose escalation study, single-arm Primary Endpoint:maximum tolerated dose or optimal biological dose Secondary Endpoint: safety and tolerability Dose: 50/100/200/400mg # Patients: 13 Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)
Hepatic Carcinoma [nimotuzumab + TACE] Primary Endpoint: toxicity Secondary Endpoints: maximum tolerated dose or optimal biological dose; overall survival; duration of response; safety and tolerability Dose: 50/100/200/400mg # Patients: 15 (enrollment ongoing) Trial Location: Cuba Lead Sponsor: Center of Molecular Immunology (CIM)

completed study

ongoing study

multi-phase study