Clinical trial · Interventional
A Single-Dose Pilot Study of Radiolabeled Amatuximab (MORAb-009) in Mesothelin Over Expressing Cancers
NCT01521325CI-TRIAL-00024112completedPhase 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)
This research is being conducted to determine the biodistribution of radiolabeled amatuximab in tumor and non-tumor tissues in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or non small cell lung cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amatuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Amatuximab infusion
- description
- Subjects will receive one infusion of radiolabeled amatuximab.
- interventionNames
- Drug: Amatuximab
Primary outcomes (1)
- measure
- Primary Objective: determine biodistribution of radiolabeled amatuximab in tumor and nontumor tissue
- timeFrame
- 1 year
- description
- To determine the biodistribution of radiolabeled amatuximab in tumor and nontumor tissue in subjects with mesothelin over expressing cancer including mesothelioma, pancreatic, ovarian or nonsmall cell lung cancer by performing SPECT imaging to determine binding to tumor and non-tumor tissue.
Secondary outcomes (5)
- measure
- Secondary objectives: determine the safety of a single IV of Indium-CHX-A amatuximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female and Male subjects \> or = 18 years of age * Histologically confirmed mesothelin-expressing cancer * Measurable disease that has progressed through prior therapy and that includes a non-hepatic lesion for imaging that is \> or = 1.5cm, as defined by RECIST v1.1 and disease location, at discretion of the physician, or evaluable by clinical symptoms supported by biomarker, radiological or pathological studies conducted within 4 weeks prior to study entry Exclusion Criteria: * Known allergy or hypersensitivity to monoclonal antibodies * Known to develop HACA * Prior treatment with amatuximab * Prior treatment with SS1 (dsFv)PE38 (ss1P) * Prior treatment with another test article within previous 30 days * Known brain metastasis * Known prosthetic devices that would prohibit imaging ow lesion of interest due to radiographic artifact * Chemotherapy, biological therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab
References
Publications (0)
Data not yet available
No reference posted for this study.