Clinical trial · Interventional
A Study of of MORAb-004 in Subjects With Solid Tumors
A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors
NCT00847054CI-TRIAL-00015101completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MORAb-004 (monoclonal antibody to TEM1) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MORAb-004
- interventionNames
- Drug: MORAb-004 (monoclonal antibody to TEM1)
Primary outcomes (1)
- measure
- To determine the safety of multiple intravenous infusions of MORAb-004
- timeFrame
- Weekly while receiving study drug
- description
- Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.
Secondary outcomes (5)
- measure
- To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range)
- timeFrame
- Weekly
- description
- Monitoring of adverse events, laboratory test results and ECG results.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.