Efficacy and PK/PD Relationship of MORAb-004 in Metastatic Melanoma

• Research type

  Research Study

• Full title

  A Study of the Efficacy and PK/PD Relationship of Monotherapy MORAb-004 in Subjects with Metastatic Melanoma

• IRAS ID

  81114

• Contact name

  Sarah Danson

• Sponsor organisation

  Morphotek, Inc

• Eudract number

  2011-001282-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma.80 subjects at 28 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2mg/kg or 4 mg/kg. Weekly treatment will continue until disease progression. Subjects are anticipated to participate for approximately 19 months.Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of systemic treatment (ie, chemotherapy) for metastatic melanoma with documentation of disease progression following treatment.Subjects will be assessed for Efficacy, Pharmacokinetic (PK)/ Pharmacodynamic (PD), Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability).MORAb-004 is a monoclonal antibody directed against endosialin, a cell surface glycoprotein, which is expressed on cells involved in tumor vasculature. Studies have found endosialin to play a key role in tumor growth and neovessel formation in numerous cancer types including melanoma. Preclinical pharmacological studies have shown that MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed to determine the efficacy of MORAb-004 at two dose levels in subjects with metastatic melanoma, as well as to establish serum pharmacokinetics and pharmacodynamics of the antibody.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0255

• Date of REC Opinion

  23 Aug 2011

• REC opinion

  Further Information Favourable Opinion