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

NCT00847054 | Completed Phase 1

• 1 other identifier: MORAb-004-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Solid Tumor

Keywords

Solid Tumor; Endosialin

Outcome Measures

Primary Outcomes (1)

• To determine the safety of multiple intravenous infusions of MORAb-004

  Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.

  Weekly while receiving study drug

Secondary Outcomes (5)

• To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range)

  Weekly

• To determine optimal biologic dose (OBD) of MORAb-004

  Weekly

• To establish the serum pharmacokinetics of MORAb-004 using a validated assay

  Weekly

• To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004

  bimonthly

• To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004

  Biweekly

Study Arms (1)

MORAb-004

EXPERIMENTAL

Drug: MORAb-004 (monoclonal antibody to TEM1)

Interventions

MORAb-004 (monoclonal antibody to TEM1) DRUG

Intravenous administration

MORAb-004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Morphotek: lead

Study Sites (3)

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21205, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

ontuxizumab

Study Officials

• Susan Weil, MD

  Morphotek

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 19, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

US (3)