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
Conditions
Brief 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.
Interventions
OTHERRadioconjugate
1241-hJAA-F11 IV administration
PROCEDUREPositron Emission Tomography
PET/CT Imaging
PROCEDUREComputed Tomography
PET/CT Imaging
FDG PET/CT Imaging
PROCEDUREBiospecimen Collection
Blood sample collection imaging
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of grade 3+ I-hJAA-F11 related adverse events | Up to 6 months after final PET/CT | Incidence of severe adverse events will be graded according to CTCAE ver 5 |
| Evaluate Diagnostic efficacy of I-hJAA-F11 | Within 30 days of final I/hJAA-f11 PET/CT | uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained. |
Secondary
| Measure | Time frame |
|---|---|
| Development of anti-drug antibodies | Up to approximately 8 weeks |
Outcome results
None listed