Extensive-stage Small-cell Lung CancerPhase 1NCT06427369
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
A Phase 1 study testing Radioconjugate, Positron Emission Tomography and Computed Tomography in people with Extensive-stage Small-cell Lung Cancer and Limited-stage Small-cell Lung Cancer, run by Roswell Park Cancer Institute.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-stage Small-cell Lung Cancer, Limited-stage Small-cell Lung Cancer, Lung Non-Small Cell Carcinoma
- What is being tested?
- Radioconjugate, Positron Emission Tomography and Computed Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Sep 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer.
SECONDARY OBJECTIVES:
- 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
- Being tested
- Radioconjugate, Positron Emission Tomography, Computed Tomography, FDG-Positron Emission Tomography and Computed Tomography Scan, Biospecimen Collection
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadioconjugateOther
1241-hJAA-F11 IV administration
Positron Emission TomographyProcedure or surgery
Also called PET, PET SCAN
PET/CT Imaging
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan
PET/CT Imaging
FDG-Positron Emission Tomography and Computed Tomography ScanProcedure or surgery
Also called FDG PET/CT
FDG PET/CT Imaging
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Blood sample collection imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radioconjugate; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 3+ I-hJAA-F11 related adverse events
Incidence of severe adverse events will be graded according to CTCAE ver 5
Measured: 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.
Measured: Within 30 days of final I/hJAA-f11 PET/CT
Secondary outcomes (1)
Development of anti-drug antibodies
Measured: Up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Why it stopped: prioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-stage Small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace Dy, MD, Principal investigator, Roswell Park Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427369
- Sponsor's protocol ID
- I -1774023
- Status last verified
- Sep 2024
- First submitted
- 17 May 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11
- ClinicalTrials.gov ID
- NCT06427369
- Acronym / sponsor ID
- I -1774023
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: prioritization
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the safety and diagnostic efficacy of 124I-hJAA-F11 in detecting lung cancer.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | Experimental | Other: Radioconjugate, Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan, Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioconjugate1241-hJAA-F11 IV administration | Other | Diagnostic |
| Positron Emission TomographyAlso: PET, PET SCANPET/CT Imaging | Procedure or surgery | Diagnostic |
| Computed TomographyAlso: CAT, CAT ScanPET/CT Imaging | Procedure or surgery | Diagnostic |
| FDG-Positron Emission Tomography and Computed Tomography ScanAlso: FDG PET/CTFDG PET/CT Imaging | Procedure or surgery | Diagnostic |
| Biospecimen CollectionAlso: Biological Sample CollectionBlood sample collection imaging | Procedure or surgery | Diagnostic |
Primary outcome
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
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.
1 secondary outcome
Development of anti-drug antibodies
Time frame: Up to approximately 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Dy, MD principal investigator
Roswell Park Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radioconjugate, Positron Emission Tomography and Computed Tomography in people with Extensive-stage Small-cell Lung Cancer and Limited-stage Small-cell Lung Cancer, run by Roswell Park Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade 3+ I-hJAA-F11 related adverse events (time frame: Up to 6 months after final PET/CT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.