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

June 1, 2026 updated by: Abscint NV/SA

Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) Targeted Positron Emission Tomography and Computed Tomography (PET/CT) With 68Ga-ABS011 in Metastatic Breast Cancer (mBC) and Other Metastatic Solid Carcinomas.

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Lesion sampling error resulting tumor heterogeneity is probably the biggest pitfall when determining the HER2 status. Moreover, IHC expression or gene amplification can be affected by procedural differences and sample handling differences that are influenced by the experience and training of the pathologist's team. Last but not least, immunohistochemistry interpretation remains a semiquantitative subjective scoring which is susceptible to considerable interobserver variability.

68Ga-ABS011, is a NOTA (chelating agent to label sdAbs with radionuclides) linked 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. The available preclinical and clinical results with 68Ga-ABS011 (or its first generation product), including a phase I and a phase II clinical trials, did not reveal any safety signals. Extended safety assessments, including anti-drug antibody (ADA) serum evaluations after 2 consecutive administrations, supported the previously observed low immunogenicity risk profile with these sdAbs. Besides safety, this tracer showed potential in the assessment of inter-lesional HER2 expression heterogeneity and also displayed some higher sensitive and more specific determination of disease extent compared to 18F-FDG.

Whole body mapping of HER2, an antigen present in multiple cancer types, might (I) Reduce tumor lesion sampling errors and resultingly reduce false negative HER2 IHC outcomes, potentially broadening the therapeutic and interventional treatment options for the patient; (II) Enable identification of inter-and intratumor heterogeneity; and (III) Support follow-up of HER2 targeted treatment response, and accompanied treatment decisions.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, A-6020
  • Belgium
      • Leuven, Belgium
        • Recruiting
        • University Hospital Gasthuisberg
        • Contact:
          • Karolien Goffin, Prof.Dr.
        • Contact:
          • Hans Wildiers, Prof.Dr.
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium, 1070
        • Recruiting
        • Institut Jules Bordet
        • Contact:
          • E. De Azambuja, Prof.Dr.
      • Brussels, Brussels Capital, Belgium, 1070
        • Recruiting
        • AZ Delta CHIREC
        • Contact:
          • C. Closset, Dr.
        • Contact:
          • A. Awada, Prof.Dr.
      • Brussels, Brussels Capital, Belgium, 1070
        • Recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
          • F. Duhoux, Prof.Dr.
      • Brussels, Brussels Capital, Belgium, 1070
        • Recruiting
        • Free University Brussels (VUB)
        • Contact:
          • C. Fontaine, Dr.
    • East-Flanders
      • Aalst, East-Flanders, Belgium, 9300
        • Completed
        • OLV Aalst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-ABS011 PET/CT
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive, negative, and overall diagnostic agreement between 68Ga-ABS011 PET/CT and the standard of care IHC (and ISH) HER2 status test.
Time Frame: immediately after the 68Ga-ABS011 PET/CT procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of 68Ga-ABS011.
Time Frame: up to 6 weeks after initiation of the HER2 targeted monotherapy
Incidence rate of all adverse events (AEs) and serious AEs (SAEs)
up to 6 weeks after initiation of the HER2 targeted monotherapy
Change in treatment management
Time Frame: immediately after the 68Ga-ABS011 PET/CT procedure
Proportion of patients for whom the whole body 68Ga-ABS011 PET/CT guided biopsy impacted the management of the mBC
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)
Time Frame: 6 weeks after initiation of the HER2 targeted monotherapy
Positive and negative predictive value and likelihood ratio of 68Ga-ABS011 using 18F-FDG PET/ceCT as a reference.
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)
Time Frame: 6 weeks after initiation of the HER2 targeted monotherapy
Positive and negative predictive value and likelihood ratio of 68Ga-ABS011 using 18F-FDG PET/ceCT as a reference.
6 weeks after initiation of the HER2 targeted monotherapy
Tumor heterogeneity
Time Frame: immediately after the 68Ga-ABS011 PET/CT procedure
Inter-tumor heterogeneity assessment by measuring the proportion of discordance between the total number of lesions and number of overlapping lesions confirmed on 18F-FDG and/or 68Ga-ABS011 PET/CT.
immediately after the 68Ga-ABS011 PET/CT procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abscint NV/SA

Investigators

  • Principal Investigator: Géraldine Gebhart, Institut Jules Bordet Brussels
  • Principal Investigator: Evandro De Azambuja, Institut Jules Bordet Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABS011-1
  • 2024-511419-22-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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