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

NCT06427369 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: I -1774023
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Development of anti-drug antibodies

  Up to approximately 8 weeks

Study Arms (1)

Diagnostic

EXPERIMENTAL

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.

Other: Radioconjugate; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan; Procedure: Biospecimen Collection

Interventions

Radioconjugate OTHER

1241-hJAA-F11 IV administration

Diagnostic

Positron Emission Tomography PROCEDURE

PET/CT Imaging

Also known as: PET, PET SCAN

Diagnostic

Computed Tomography PROCEDURE

PET/CT Imaging

Also known as: CAT, CAT Scan

Diagnostic

FDG-Positron Emission Tomography and Computed Tomography Scan PROCEDURE

FDG PET/CT Imaging

Also known as: FDG PET/CT

Diagnostic

Biospecimen Collection PROCEDURE

Blood sample collection imaging

Also known as: Biological Sample Collection

Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Grace Dy, MD

  Roswell Park Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 27, 2024

Record last verified: 2024-09