Lung Non-Small Cell Carcinoma Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
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 |
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