Using 68Ga-ABS011 for imaging HER2 in metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study evaluates the diagnostic performance of 68Ga-ABS011 PET/CT in determining HER2 expression status in patients with metastatic breast cancer. The study aims to compare the accuracy of 68Ga-ABS011 against standard diagnostic methods such as immunohistochemistry and imaging tools. By addressing issues like tumor heterogeneity and interobserver variability in HER2 status determination, the study seeks to improve treatment decision-making for patients. Participants will undergo PET/CT imaging with 68Ga-ABS011 and may also have tumor biopsies to assess HER2 status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult (≥ 18 years at the time of informed consent signature) male or female patient
2. Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed).

   2.1. 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 .
3. 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).
4. Patient willing to undergo at least one tumor biopsy.
5. Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases.
6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to
7. Ability and willingness of the research participant to provide written informed consent.

Exclusion Criteria:

1. Primary (non-metastatic) solid tumor cancer.
2. 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.
3. 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
4. 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.
5. Brain and liver metastases are the sole sites of metastatic disease.
6. Life expectancy lower than 3 months.
7. Pregnancy or breastfeeding.
8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results:

   1. Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2.
   2. Absolute neutrophil count \<1,500 cells/mm3.
   3. Total bilirubin \~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome).
   4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) \>5.0 x ULN.
9. Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging.
10. Patients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed).
11. Patients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate pre-medication).
12. Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).
13. Any condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements).

Where it's running

• Medizinische Universität Innsbruck
  Innsbruck, Tyrol, Austria Recruiting
• AZ Delta CHIREC
  Brussels, Brussels Capital, Belgium Recruiting
• Cliniques Universitaires Saint-Luc
  Brussels, Brussels Capital, Belgium Recruiting
• Free University Brussels (VUB)
  Brussels, Brussels Capital, Belgium Recruiting
• Institut Jules Bordet
  Brussels, Brussels Capital, Belgium Recruiting
• University Hospital Gasthuisberg
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Géraldine Gebhart — Institut Jules Bordet Brussels
• Study coordinator: Karine Clauwaert
• Email: karine.clauwaert@abscint.com
• Phone: +32476536594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.