TheranosticTrials.org

Clinical Trial · NCT06369831

HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011

Overview

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).

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Géraldine Gebhart (PRINCIPAL_INVESTIGATOR)

Evandro De Azambuja (PRINCIPAL_INVESTIGATOR)

Karine Clauwaert (CONTACT)

karine.clauwaert@abscint.com

+32476536594

Dieter Frijns (CONTACT)

dieter.frijns@abscint.com

+32473337625

ClinicalTrials.gov

NCT06369831

Drug / Compound

ABS011

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patient willing to undergo at least one tumor biopsy.
  • 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).
  • 1. 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).
  • 1. Patients with documented hormone receptor positive/HER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study) or 2.2 Other metastatic solid tumors, not necessarily eligible for commercially available HER2 targeted monotherapy .

Exclusion

  • 1. Primary (non-metastatic) solid tumor cancer.
  • Brain and liver metastases are the sole sites of metastatic disease.
  • 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
  • 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.
  • 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.