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

Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427369
• Other study ID #: I -1774023
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 1, 2024
• Est. completion date: September 1, 2027

Study information

• Verified date: May 2024
• Source: Roswell Park Cancer Institute
• Contact: ASK RPCI
• Phone: 1-877-275-7724
• Email: Askrpci[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Extensive-stage Small-cell Lung Cancer
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Small Cell Lung Carcinoma
• Stage IV Lung Cancer

Intervention

Other:
• Radioconjugate
1241-hJAA-F11 IV administration

Procedure:
• Positron Emission Tomography
PET/CT Imaging
• Computed Tomography
PET/CT Imaging
• FDG-Positron Emission Tomography and Computed Tomography Scan
FDG PET/CT Imaging
• Biospecimen Collection
Blood sample collection imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Development of anti-drug antibodies		Up to approximately 8 weeks