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Carcinoma, Pancreatic DuctalEarly Phase 1NCT01413451

Amatuximab for High Mesothelin Cancers

A Early Phase 1 study testing Amatuximab (MORab-009) in people with Carcinoma, Pancreatic Ductal and Mesothelioma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Background: Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Amatuximab (MORab-009)
How many people
7 participants
Where
1 siteUnited States
Study dates
12 Jul 2011to 15 Nov 2013
Phase
Early 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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male subjects, greater than or equal to 18 years of age.
  • Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma, mesothelin-positive ovarian cancer, or NSCLC. A new biopsy is not required; the diagnostic biopsy sample will be sufficient. IHC confirmation of mesothelin-positivity is not necessary for pancreatic adenocarcinoma and mesothelioma as nearly 100% of pancreatic adenocarcinomas and mesotheliomas express mesothelin. Mesothelin expression in ovarian cancer and NSCLC will be tested by IHC and any degree of positivity (1+, 2+, or 3+) will be accepted.
  • Subjects are required to have measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is greater than or equal to 1.5 cm, as defined by Modified Response Evaluation Criteria in Solid Tumors (RECIST).
  • Eastern Cooperative Oncology Group (ECOG) performance status or 0, 1, or 2.
  • Female subjects of childbearing potential and all male subjects are required to consent to use a medically acceptable method of contraception throughout the study period and for 30 days after amatuximab administration. A barrier method of contraception is required.
  • Laboratory and clinical results within the 2 weeks prior to Day of Infusion as follows:
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  • Absolute neutrophil count (ANC): greater than or equal to 1.5 times 10(9)/L
  • Platelet count: greater than or equal to 75 times 10(9)/L
  • Hemoglobin: greater than or equal to 9 g/dL
  • Serum bilirubin: less than or equal to 1.5 mg/dL
  • Aspartate transaminase (AST): less than or equal to 3 x upper limit of normal (ULN) (less than or equal to 5 ULN acceptable for pancreatic patients with known liver metastasis only)
  • Alanine transaminase (ALT) less than or equal to 3 times upper limit of normal (ULN) (less than or equal to 5 ULN acceptable for pancreatic patients with known liver metastasis only)
  • Alkaline Phosphatase less than or equal to 5 times ULN
  • Serum creatinine less than or equal to 1.5 mg/dL
  • Subjects are required to be willing and able to provide written informed consent.

Who cannot join

  • Subjects are ineligible to participate in this study if any of the following criteria are met:
  • Known allergy or hypersensitivity to monoclonal antibodies;
  • Prior treatment with amatuximab;
  • Prior treatment with SS1(dsFv)PE38 (SS1P);
  • Known brain metastases;
  • Known prosthetic devices that would prohibit imaging of lesion of interest due to radiographic artifact;
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  • Evidence of other active malignancy requiring treatment;
  • 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);
  • ECG demonstrating clinically significant arrhythmias. Subjects with chronic atrial arrhythmia, (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia), are eligible;
  • Active serious systemic disease, including active bacterial or fungal infection within 2 weeks before study entry;
  • Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection;
  • Treatment within 3 months with immunomodulatory therapy (e.g., interferons, immunoglobulin therapy, Interleukin 1 receptor antagonist (IL-1RA) or systemic corticosteroids). Short-term systemic corticosteroids or topical or intra-articular steroids are acceptable, at the discretion of the Investigator;
  • Chemotherapy, biologic therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab;
  • Breast-feeding, pregnant, or likely to become pregnant during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers

Background:

  • Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin.
Read more

Objectives:

  • To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin.

Eligibility:

  • Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin.

Design:

  • Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies.
  • Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer.
  • Participants will have a third imaging study of the cancer about 1 week after the infusions.
  • Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.
Read the detailed description

Background:

  • Amatuximab is a high-affinity monoclonal IgG antibody raised against human mesothelin.
  • Mesothelin is a glycosyl-phosphatidyl inositol-linked membrane glycoprotein thought to be involved in tumor metastasis
  • Mesothelin is over-expressed in many cancers

Objectives:

-The primary objective is to determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissues in subjects with mesothelin over-expressing cancers including mesothelioma, pancreatic, ovarian, and non small cell lung cancer.

Eligibility:

  • Female or male subjects greater than or equal to 18 years of age;
  • Histologically confirmed mesothelin-expressing cancer;
  • Transaminases less than or equal to 3 times ULN for mesothelioma, non small cell lung and ovarian cancer;
  • Transaminases less than or equal to 5 times ULN for pancreatic cancer with known liver metastasis.

Design:

  • This is a single-center, single-dose, open-label, pilot study of MORAb-009 in approximately 20 subjects with mesothelin expressing tumors.
  • Indium-radiolabeled MORAb-009 (5mCi) will be administered.
  • Serial single photon emission-computerized tomography imaging will be performed to determine binding to tumor and nontumor tissue.
  • Subjects will be observed closely for safety and possible development of anti-MORAb-009 antibodies.
  • Pharmacokinetics of radiolabeled antibody will be determined with imaging over time.
Being tested
Amatuximab (MORab-009)
Keywords
Monoclonal IgG Antibody, Biodistribution, Pharmacokinetics, HACA, Safety, Mesothelioma, Ovarian Cancer, Pancreatic Duct Cancer, Non-Small Cell Lung Cancer
Medical subject headings
Carcinoma, Pancreatic Ductal, Mesothelioma, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amatuximab (MORab-009)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biodistribution of radiolabelled amatuximab in tumor and nontumor tissues.

  2. Tumor

  3. Background ratio of maximum counts

Secondary outcomes (4)

  1. CTCAE V.4 events

  2. Observation of HACA

  3. PKs

  4. Antibody uptake vs. IHC mesothelin expression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2011 (estimated)
  2. Study start12 Jul 2011
  3. Primary completion15 Nov 2013
  4. Study completion15 Nov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01413451
Sponsor's protocol ID
110212
Other IDs
11-C-0212
Status last verified
15 Nov 2013
First submitted
9 Aug 2011
Last updated
17 Dec 2019
Results posted
No

Publications

  • Hassan R, Ebel W, Routhier EL, Patel R, Kline JB, Zhang J, Chao Q, Jacob S, Turchin H, Gibbs L, Phillips MD, Mudali S, Iacobuzio-Donahue C, Jaffee EM, Moreno M, Pastan I, Sass PM, Nicolaides NC, Grasso L. Preclinical evaluation of MORAb-009, a chimeric antibody targeting tumor-associated mesothelin. Cancer Immun. 2007 Dec 19;7:20.

    PubMed 18088084

  • Hassan R, Ho M. Mesothelin targeted cancer immunotherapy. Eur J Cancer. 2008 Jan;44(1):46-53. doi: 10.1016/j.ejca.2007.08.028. Epub 2007 Oct 22.

    PubMed 17945478

  • Gubbels JA, Belisle J, Onda M, Rancourt C, Migneault M, Ho M, Bera TK, Connor J, Sathyanarayana BK, Lee B, Pastan I, Patankar MS. Mesothelin-MUC16 binding is a high affinity, N-glycan dependent interaction that facilitates peritoneal metastasis of ovarian tumors. Mol Cancer. 2006 Oct 26;5(1):50. doi: 10.1186/1476-4598-5-50.

    PubMed 17067392

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Amatuximab (MORab-009) in people with Carcinoma, Pancreatic Ductal and Mesothelioma, run by National Cancer Institute (NCI) at 1 site 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 15 inclusion and 14 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: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 was stopped early. Results are not available in the source record.

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?

Biodistribution of radiolabelled amatuximab in tumor and nontumor tissues.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01413451, which also lists 3 linked publications.

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 17 Dec 2019.

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