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A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumor

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Trial Information

A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors

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
(but not limited to) renal, breast, colon, pancreatic, lung, endometrial, ovarian, melanoma,
sarcoma, and neuroectodermal tumors. Preclinical pharmacological studies have shown that
MORAb-004 is a potentially useful anti-cancer agent. This clinical trial is being performed
to determine the safety of MORAb-004 in subjects with solid tumors, as well as to establish
serum pharmacokinetics of the antibody, and to assess tumor antigens that may serve as
predictors of a response to MORAb-004. Study Part 2 was added to enroll subjects with
specific histological diagnoses (colorectal cancer and soft tissue sarcoma) to further
characterize the safety and tolerability of 5 dose levels of MORAb-004 previously tested
during the dose escalation in Part 1.

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

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

Weekly while receiving study drug

Safety Issue:


Principal Investigator

Susan Weil, MD

Investigator Role:

Study Director

Investigator Affiliation:

Morphotek, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

October 2013

Related Keywords:

  • Solid Tumor
  • Solid Tumor
  • Endosialin
  • Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland  21231