A Study of of MORAb-004 in Subjects With Solid Tumors

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Subjects ≥18 years of age.

• Subjects with any malignant solid tumor without intracranial involvement or metastases diagnosed by standard pathology criteria that has failed standard chemotherapy.

• Subject must have disease, as defined by RECIST or evaluable by clinical signs/symptoms (e.g., ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry.

• Karnofsky performance status ≥70%.

• Female subjects of childbearing potential and all male subjects must consent to use a medically acceptable method of contraception throughout the study period and for 30 days after MORAb-004 administration. A barrier method of contraception must be included.

• Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:

Absolute neutrophil count (ANC) ≥1.5 x 109/L; Platelet count ≥100 x 109/L; Hemoglobin ≥10 g/dL; Serum bilirubin ≤2.0 mg/dL; Aspartate transaminase (AST) ≤2.5 x ULN; or ≤5 x ULN if liver metastases are present; Alanine transaminase (ALT) ≤2.5 x ULN; or ≤5 x ULN if liver metastases are present; Serum creatinine ≤2.0 mg/dL; prothrombin time (PT) and aPTT within institutional limits of normal.

• Subject must be willing and able to provide written informed consent.

• In Part 2 (expansion cohorts) ONLY, subjects must have a histological diagnosis of either CRC or STS (and subtypes, excluding bone sarcomas).

Exclusion Criteria:

• Known central nervous system (CNS) tumor involvement or metastases.

• Evidence of other active malignancy.

• Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months).

• Electrocardiogram (ECG) demonstrating clinically significant arrhythmias (Note:

Subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal SVT, are eligible).

• Presence of severe lung disease (In the absence of clinically apparent severe lung disease, no formal testing is necessary. In the presence of clinically severe lung disease, FEV1 must be >60% in order for the subject to be eligible.)

• Active serious systemic disease, including active bacterial or fungal infection.

• Chronic inflammatory disorder, e.g., inflammatory bowel disease, active vasculitis.

• Chemotherapy, biologic therapy, or immunotherapy within 3 weeks prior to enrollment.

• Breast-feeding, pregnant, or likely to become pregnant during the study.

• Active hepatitis or human immunodeficiency virus (HIV) infection.

• Subjects who have received a previous monoclonal antibody therapy and have evidence of an immune or allergic reaction, or previously documented human anti-human antibody (HAHA).

• Subjects with large ascites or pleural effusion (≥500 cc) based on results of most recent CT scan).

• Chronic systemic anticoagulation therapy with warfarin or heparin