HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbscint NV/SA
About this trial
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (≥ 18 years at the time of informed consent signature) male or female patient
Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed).
Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET/ceCT assessment).
Patient willing to undergo at least one tumor biopsy.
Disqualifiers
Primary (non-metastatic) solid tumor cancer.
Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC/ISH analyses, completed before screening, will not be accepted for study purposes.
18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
Metastatic setting 18F-FDG PET/ceCT indicating that the identified tumor lesions cannot be biopsied due their location and/or tissue type and/or an increased risk for serious comorbidities.
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-NOTA-ABSCINT-HER2 PET/CT
Diagnostic test68Ga-ABS011, is a single domain antibody (sdAb) with the capability to bind HER2 tumor antigens very fast, while the unbound fraction is rapidly cleared from the blood. ABS011 is labeled with gallium-68, a short-lived isotope (68Ga, t1/2: 68 min). Combining rapid targeting of HER2, fast clearance and low radiation burden make 68Ga-ABS011 is suited for specific tumor marker whole body PET/CT imaging.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: 68Ga-ABS011 PET/CTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test.
Evaluation, on a per-lesion level, of the diagnostic performance (positive, negative, and overall diagnostic agreement compiled of ratios between true positive, true negative, false psoitive and false negative 68Ga-ABS011 PET/CT results)) of 68Ga-ABS011 PET/CT(III) compared to HER2 IHC (and ISH) status.
Time frame
immediately after the 68Ga-ABS011 PET/CT procedureSecondary outcomes
1
Safety of 68Ga-ABS011.
Incidence rate of all adverse events (AEs) and serious AEs (SAEs)
Time frame
up to 6 weeks after initiation of the HER2 targeted monotherapy2
Change in treatment management
Proportion of patients for whom the whole body 68Ga-ABS011 PET/CT guided biopsy impacted the management of the mBC
Time frame
immediately after the 68Ga-ABS011 PET/CT procedure3
reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage)
Positive and negative predictive value and likelihood ratio of 68Ga-ABS011 using 18F-FDG PET/ceCT as a reference.
Time frame
6 weeks after initiation of the HER2 targeted monotherapy4
reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response)
Positive and negative predictive value and likelihood ratio of 68Ga-ABS011 using 18F-FDG PET/ceCT as a reference.
Time frame
6 weeks after initiation of the HER2 targeted monotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov