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

September 25, 2024 updated by: Roswell Park Cancer Institute

Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Radioconjugate
1241-hJAA-F11 IV administration
Procedure: Positron Emission Tomography
PET/CT Imaging
Other Names:
  • PET
  • PET SCAN
Procedure: Computed Tomography
PET/CT Imaging
Other Names:
  • CAT
  • CAT Scan
Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan
FDG PET/CT Imaging
Other Names:
  • FDG PET/CT
Procedure: Biospecimen Collection
Blood sample collection imaging
Other Names:
  • Biological Sample Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of grade 3+ I-hJAA-F11 related adverse events
Time Frame: Up to 6 months after final PET/CT
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
Time Frame: 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.
Within 30 days of final I/hJAA-f11 PET/CT

Secondary Outcome Measures

Outcome Measure
Time Frame
Development of anti-drug antibodies
Time Frame: Up to approximately 8 weeks
Up to approximately 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Principal Investigator: Grace Dy, MD, Roswell Park Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 23, 2024

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I -1774023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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