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Clinical Trials

For details about clinical trials with YM BioSciences products, move your mouse over the indications below.

Nimotuzumab Global Clinical Development - YM BioSciences/CIMYM 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 CLOSED 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 Trial Location: Canada, US, Europe Lead Sponsor: YM BioSciences
Brain Metastasis from Non-Small Cell Lung Cancer first line or later [whole-brain radiation +/- nimotuzumab] STUDY CLOSED 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 Trial Location: Canada, US, Europe 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 complete) Trial Locations: Canada, US Lead Sponsor: YM BioSciences
Pediatric Brain Stem Tumors (Expanded Access ) recurrent [monotherapy] Expanded Access Program Trial Location: US 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-11; 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

Nimotuzumab Global Clinical Development - CIMAB 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: Biocon
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)

CYT387 Clinical Development

Indication	Phase I	Phase II	Phase III	Publications
Myelofibrosis CYT387 (oral) monotherapy BID Study Design: (Part 1) dose-escalation enrolling successive patient cohorts dosed starting at 200mg BID, escalating at 50mg BID per cohort; (Part 2) dose-confirmation evaluating patients at or below MTD determined in Part 1 Primary Endpoints: maximum tolerated dose, safety and tolerability, efficacy # Patients: 60 (enrollment ongoing) Trial Location: United States, Canada Lead Sponsor: YM BioSciences Australia
Myelofibrosis CYT387 (oral) monotherapy Study Design: dose-escalation with cohort expansion at biologically active doses Primary Endpoints: dose-limiting toxicities, maximum tolerated dose, safety and tolerability Secondary Endpoints: effect on spleen size, hematological symptoms, quality of life, markers of aberrant JAK2 activity in blood # Patients: 166 (enrollment complete) Trial Location: United States, Australia Lead Sponsor: YM BioSciences Australia

CYT997 Clinical Development