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

NCT ID: NCT06427369

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-09-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic

Patients receive 124I-hJAA-F11 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.

Group Type: EXPERIMENTAL

Radioconjugate

Intervention Type: OTHER

1241-hJAA-F11 IV administration

Positron Emission Tomography

Intervention Type: PROCEDURE

PET/CT Imaging

Computed Tomography

Intervention Type: PROCEDURE

PET/CT Imaging

FDG-Positron Emission Tomography and Computed Tomography Scan

Intervention Type: PROCEDURE

FDG PET/CT Imaging

Biospecimen Collection

Intervention Type: PROCEDURE

Blood sample collection imaging

Interventions

Radioconjugate

1241-hJAA-F11 IV administration

Intervention Type: OTHER

Positron Emission Tomography

PET/CT Imaging

Intervention Type: PROCEDURE

Computed Tomography

PET/CT Imaging

Intervention Type: PROCEDURE

FDG-Positron Emission Tomography and Computed Tomography Scan

FDG PET/CT Imaging

Intervention Type: PROCEDURE

Biospecimen Collection

Blood sample collection imaging

Intervention Type: PROCEDURE

Other Intervention Names

PET; PET SCAN; CAT; CAT Scan; FDG PET/CT; Biological Sample Collection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace Dy, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Comprehensive Cancer Center

Other Identifiers

I -1774023

Identifier Type: -

Identifier Source: org_study_id