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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06427369
Other study ID # I -1774023
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date September 1, 2024
Est. completion date September 1, 2027

Study information

Verified date May 2024
Source Roswell Park Cancer Institute
Contact ASK RPCI
Phone 1-877-275-7724
Email Askrpci@roswellpark.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date September 1, 2027
Est. primary completion date September 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee [AJCC] 8th edition) - Patients undergoing FDG-PET scan as standard of care testing. - Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of = 2 - Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: - Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or nursing female participants

Study Design


Intervention

Other:
Radioconjugate
1241-hJAA-F11 IV administration
Procedure:
Positron Emission Tomography
PET/CT Imaging
Computed Tomography
PET/CT Imaging
FDG-Positron Emission Tomography and Computed Tomography Scan
FDG PET/CT Imaging
Biospecimen Collection
Blood sample collection imaging

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Roswell Park Cancer Institute

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of grade 3+ I-hJAA-F11 related adverse events Incidence of severe adverse events will be graded according to CTCAE ver 5 Up to 6 months after final PET/CT
Primary Evaluate Diagnostic efficacy of I-hJAA-F11 uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained. Within 30 days of final I/hJAA-f11 PET/CT
Secondary Development of anti-drug antibodies Up to approximately 8 weeks
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