Trials / Withdrawn
WithdrawnNCT06427369
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase I trial studies the side effects of 124I-hJAA-F11, and evaluates how well it works in diagnosing lung cancer. 124I-hJAA-F11 uses a known radioactive substance used in imaging called iodine 124 (124I). hJAA-F11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. In animal studies, hJAA-F11 has shown anti-tumor activity against tumors bearing the Thomsen-Friedenreich antigen that is found in over 90% of lung cancers. 124I-hJAA-F11 has the 124I radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer.
Detailed description
PRIMARY OBJECTIVE: I. To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer. SECONDARY OBJECTIVES: I. To assess the development of anti-drug antibodies following administration of 124I-hJAAF11. II. To characterize concordance in lesions characterized by 124I-hJAA-F11-based positron emission tomography/computed tomography (PET/CT) compared to standard of care FDG (fluorodeoxyglucose)-PET. III. To perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms. OUTLINE: Patients receive 124I-hJAA-F11 intravenously (IV) on day 0. Patients then undergo PET/CT on day 1 (20-28 hours post 124I-hJAA-F11), day 2 (48-96 hours post 124I-hJAA-F11), day 5-6 (120-144 hours post 124I-hJAA-F11), and day 7-8 (168-192 hours post 124I-hJAA-F11). Patients also undergo FDG PET/CT during screening and undergo blood sample collection throughout the trial. After completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months.
Conditions
- Extensive-stage Small-cell Lung Cancer
- Limited-stage Small-cell Lung Cancer
- Lung Non-Small Cell Carcinoma
- Stage IIIA Lung Cancer
- Stage IV Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Radioconjugate | 1241-hJAA-F11 IV administration |
| PROCEDURE | Positron Emission Tomography | PET/CT Imaging |
| PROCEDURE | Computed Tomography | PET/CT Imaging |
| PROCEDURE | FDG-Positron Emission Tomography and Computed Tomography Scan | FDG PET/CT Imaging |
| PROCEDURE | Biospecimen Collection | Blood sample collection imaging |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2024-05-23
- Last updated
- 2024-09-27
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06427369. Inclusion in this directory is not an endorsement.