Amatuximab for High Mesothelin Cancers
Public ClinicalTrials.gov record NCT01413451. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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. 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.
Study identification
- NCT ID
- NCT01413451
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 7 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 12, 2011 (Type not available)
- Primary completion
- Nov 15, 2013 (Actual)
- Completion
- Nov 15, 2013 (Actual)
- Last update posted
- Dec 17, 2019
2011 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01413451, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 17, 2019 · Synced Sep 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01413451 live on ClinicalTrials.gov.