Efficacy Study of Pharmacokinetic(PK)/Pharmacodynamic(PD) Relationship of Monotherapy MORAb-004 in Metastatic Melanoma
Trial Purpose and Description
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 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression.
Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy.
Subjects will be assessed for Efficacy, PK/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.
- 18 Years and older
- Histologically confirmed diagnosis of metastatic melanoma
- At least one prior line of systemic treatment with confirmed progression of disease
- Measurable disease, as defined by RECIST, assessed within 4 wks prior to study entry
- At least 3 week interval between first infusion of test article and most recent prior
systemic anticancer therapy
- ECOG Performance Status of 0 or 1
- Evidence of other active malignancy requiring treatment within the last 5 years
(other than basal cell or squamous cell carcinoma of the skin), or active brain
- Clinically significant heart disease (Congestive heart failure of NYHA Class 3 or 4,
angina not well controlled by medication, or myocardial infarction within 6 mos.), or
ECGs demonstrating clinically significant arrhythmias
- Brain metastasis
- Known allergic reaction to a prior monoclonal antibody therapy
- Previous treatment with MORAb-004
- April 2011
- Last Updated:
- October 21, 2013
- Study HIC#:
Clinicaltrials.gov ID: NCT01335009