HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011

NCT06369831 | Recruiting Phase 2 DMC

• 2 other identifiers: ABS011-12024-511419-22-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Metastatic Breast Cancer

Keywords

radiolabeled; single domain antibody; 68Ga; Gallium-68; HER2; PET/CT

Outcome Measures

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.

  immediately after the 68Ga-ABS011 PET/CT procedure

Secondary Outcomes (5)

• Safety of 68Ga-ABS011.

  up to 6 weeks after initiation of the HER2 targeted monotherapy

• Change in treatment management

  immediately after the 68Ga-ABS011 PET/CT procedure

• reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (Early tumor shrinkage)

  6 weeks after initiation of the HER2 targeted monotherapy

• reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (metabolic response)

  6 weeks after initiation of the HER2 targeted monotherapy

• Tumor heterogeneity

  immediately after the 68Ga-ABS011 PET/CT procedure

Study Arms (1)

68Ga-ABS011 PET/CT

EXPERIMENTAL

All Hormone receptor positive/HER2 negative, triple-negative or HER2 positive metastatic Breast Cancer (mBC) patients will undergo a HER2 targeted PET/CT using 68Ga-ABS011 after completion of a 18F-FDG PET/CT and lesion biopsy (and IHC/ISH analysis).

Diagnostic Test: 68Ga-NOTA-ABSCINT-HER2 PET/CT

Interventions

68Ga-NOTA-ABSCINT-HER2 PET/CT DIAGNOSTIC_TEST

68Ga-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.

68Ga-ABS011 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥ 18 years at the time of informed consent signature) male or female patient
• Patient with confirmed de novo or pre-treated mBC (multiple previous treatment lines in metastatic setting are allowed).
• 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).
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
• Ability and willingness of the research participant to provide written informed consent.

You may not qualify if:

• Primary (non-metastatic) breast 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.
• F-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.
• Brain and liver metastases are the sole sites of metastatic disease.
• Life expectancy lower than 3 months.
• Pregnancy or breastfeeding.
• Inadequate organ function, suggested by clinically relevant abnormal laboratory results:
• Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2.
• Absolute neutrophil count \<1,500 cells/mm3.
• Total bilirubin \~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome).
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) \>5.0 x ULN.
• Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging.
• 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).
• 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).

Sponsors & Collaborators

• Abscint NV/SA: lead

Study Sites (6)

OLV Aalst

Aalst, East-Flanders, 9300, Belgium

RECRUITING

AZ Delta CHIREC

Brussels, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1070, Belgium

RECRUITING

Free University Brussels (VUB)

Brussels, 1070, Belgium

RECRUITING

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

University Hospital Gasthuisberg

Leuven, Belgium

RECRUITING

Related Links

• Website Sponsor

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Géraldine Gebhart

  Institut Jules Bordet Brussels

  PRINCIPAL INVESTIGATOR

• Evandro De Azambuja

  Institut Jules Bordet Brussels

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karine Clauwaert

CONTACT

+32476536594; karine.clauwaert@abscint.com

Dieter Frijns

CONTACT

+32473337625; dieter.frijns@abscint.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional, Phase IIb, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients)

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: September 12, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2024-09

Locations

BE (6)