An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer

Roswell Park Cancer Institute

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

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

RadioconjugateOTHER

1241-hJAA-F11 IV administration

Positron Emission TomographyPROCEDURE

PET/CT Imaging

Computed TomographyPROCEDURE

PET/CT Imaging

FDG-Positron Emission Tomography and Computed Tomography Scan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of grade 3+ I-hJAA-F11 related adverse events

Incidence of severe adverse events will be graded according to CTCAE ver 5

Time frame: Up to 6 months after final PET/CT

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.

Time frame: Within 30 days of final I/hJAA-f11 PET/CT

Secondary Outcomes

Development of anti-drug antibodies

Time frame: Up to approximately 8 weeks

Data from ClinicalTrials.gov

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