Solid TumorPhase 1NCT00847054
A Study of of MORAb-004 in Subjects With Solid Tumors
A Phase 1 study testing MORAb-004 (monoclonal antibody to TEM1) in people with Solid Tumor, run by Morphotek at 3 sites in United States.
Trial summary
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- MORAb-004 (monoclonal antibody to TEM1)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.
Read the detailed description
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.
- Conditions
- Solid Tumor
- Being tested
- MORAb-004 (monoclonal antibody to TEM1)
- Keywords
- Solid Tumor, Endosialin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-004 (monoclonal antibody to TEM1)Drug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| MORAb-004 | Experimental | Not described Receives: Drug: MORAb-004 (monoclonal antibody to TEM1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of multiple intravenous infusions of MORAb-004
Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.
Measured: Weekly while receiving study drug
Secondary outcomes (5)
To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range)
Monitoring of adverse events, laboratory test results and ECG results.
Measured: Weekly
To determine optimal biologic dose (OBD) of MORAb-004
Monitoring of adverse events, laboratory evaulations and ECG results.
Measured: Weekly
To establish the serum pharmacokinetics of MORAb-004 using a validated assay
Serial serum PK evaluations.
Measured: Weekly
To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004
CT or MRI evaluations following every other 4-week cycle.
Measured: bimonthly
To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004
Biweekly serum collection for detection of HAHA during treatment.
Measured: Biweekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Morphotek
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Weil, MD, Study director, Morphotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847054
- Sponsor's protocol ID
- MORAb-004-001
- Status last verified
- Jul 2014
- First submitted
- 5 Feb 2009
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, and Pharmacokinetics of MORAb-004, a Humanized Monoclonal Antibody, in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT00847054
- Acronym / sponsor ID
- MORAb-004-001
- Conditions
- Solid Tumor
- Keywords
- Solid Tumor, Endosialin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- MorphotekIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of multiple intravenous infusions of MORAb-004.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MORAb-004 | Experimental | Drug: MORAb-004 (monoclonal antibody to TEM1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MORAb-004 (monoclonal antibody to TEM1)Intravenous administration | Drug | MORAb-004 |
Primary outcome
To determine the safety of multiple intravenous infusions of MORAb-004
Time frame: Weekly while receiving study drug
Safety is evaluated by clinical assessment, monitoring of adverse events, laboratory evaluations, ECG.
5 secondary outcomes
To determine the maximum tolerated dose (MTD) of MORAb-004 (within the administered range)
Time frame: Weekly
To determine optimal biologic dose (OBD) of MORAb-004
Time frame: Weekly
To establish the serum pharmacokinetics of MORAb-004 using a validated assay
Time frame: Weekly
To describe changes in the objective measurements of tumor size and biomarkers (if applicable)after treatment with MORAb-004
Time frame: bimonthly
To detect any antibody response (human anti-human antibodies [HAHA] to multiple intravenous infusions of MORAb-004
Time frame: Biweekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Weil, MD study director
Morphotek
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MORAb-004 (monoclonal antibody to TEM1) in people with Solid Tumor, run by Morphotek at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety of multiple intravenous infusions of MORAb-004 (time frame: Weekly while receiving study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.