Metastatic Breast CancerPhase 2HERMIANCT06369831
HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
A Phase 2 study testing 68Ga-NOTA-ABSCINT-HER2 PET/CT in people with Metastatic Breast Cancer and Metastatic Solid Cancer, run by Abscint NV/SA at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Metastatic Solid Cancer
- What is being tested?
- 68Ga-NOTA-ABSCINT-HER2 PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 12 Sep 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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 .
- 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
- Ability and willingness of the research participant to provide written informed consent.
Who cannot join
- 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.
- Brain and liver metastases are the sole sites of metastatic disease.
- Life expectancy lower than 3 months.
Show all 17Show fewer
- 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).
- Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).
- 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).
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Belgium6 sites, 5 recruiting
- Completed
OLV Aalst
Aalst, East-Flanders, 9300
- Recruiting
AZ Delta CHIREC
Brussels, Brussels Capital, 1070
C. Closset, Dr.
A. Awada, Prof.Dr.
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1070
F. Duhoux, Prof.Dr.
- Recruiting
Free University Brussels (VUB)
Brussels, Brussels Capital, 1070
C. Fontaine, Dr.
- Recruiting
Institut Jules Bordet
Brussels, Brussels Capital, 1070
E. De Azambuja, Prof.Dr.
- Recruiting
University Hospital Gasthuisberg
Leuven
Karolien Goffin, Prof.Dr.
Hans Wildiers, Prof.Dr.
Austria1 site, 1 recruiting
- Recruiting
Medizinische Universität Innsbruck
Innsbruck, Tyrol, A-6020
Daniel Egle, Prof.Dr., 0043 512 504 82477, ago.studienzentrale@i-med.ac.at
About this study
Official title: 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).
Read the 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.
- Conditions
- Metastatic Breast Cancer, Metastatic Solid Cancer
- Being tested
- 68Ga-NOTA-ABSCINT-HER2 PET/CT
- Keywords
- radiolabeled, single domain antibody, 68Ga, Gallium-68, HER2, PET/CT, metastatic cancer, metastatic solid tumor, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-ABSCINT-HER2 PET/CTDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: 68Ga-NOTA-ABSCINT-HER2 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after the 68Ga-ABS011 PET/CT procedure
Secondary outcomes (5)
Safety of 68Ga-ABS011.
Incidence rate of all adverse events (AEs) and serious AEs (SAEs)
Measured: up to 6 weeks after initiation of the HER2 targeted monotherapy
Change in treatment management
Proportion of patients for whom the whole body 68Ga-ABS011 PET/CT guided biopsy impacted the management of the mBC
Measured: 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)
Positive and negative predictive value and likelihood ratio of 68Ga-ABS011 using 18F-FDG PET/ceCT as a reference.
Measured: 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)
Positive and negative predictive value and likelihood ratio of 68Ga-ABS011 using 18F-FDG PET/ceCT as a reference.
Measured: 6 weeks after initiation of the HER2 targeted monotherapy
Tumor heterogeneity
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.
Measured: immediately after the 68Ga-ABS011 PET/CT procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start12 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, Phase IIb, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abscint NV/SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Géraldine Gebhart, Principal investigator, Institut Jules Bordet BrusselsEvandro De Azambuja, Principal investigator, Institut Jules Bordet Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369831
- Sponsor's protocol ID
- ABS011-1
- Other IDs
- 2024-511419-22-00
- Acronym
- HERMIA
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06369831
- Acronym / sponsor ID
- HERMIA / ABS011-1
- Conditions
- Metastatic Breast Cancer, Metastatic Solid Cancer
- Keywords
- radiolabeled, single domain antibody, 68Ga, Gallium-68, HER2, PET/CT, metastatic cancer, metastatic solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abscint NV/SAIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, Phase IIb, prospective, single arm radio-diagnostic study. Driven by number of biopsied lesions (and not by number of patients)
| Arm | Type | Receives |
|---|---|---|
| 68Ga-ABS011 PET/CT | Experimental | Diagnostic Test: 68Ga-NOTA-ABSCINT-HER2 PET/CTAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
- 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 .
- 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.
Key exclusion criteria (17 listed)
- 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.
- Brain and liver metastases are the sole sites of metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NOTA-ABSCINT-HER2 PET/CT68Ga-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. | Diagnostic test | 68Ga-ABS011 PET/CT |
Primary outcome
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.
5 secondary outcomes
Safety of 68Ga-ABS011.
Time frame: 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
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
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
Tumor heterogeneity
Time frame: immediately after the 68Ga-ABS011 PET/CT procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Website SponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Géraldine Gebhart principal investigator
Institut Jules Bordet Brussels
Evandro De Azambuja principal investigator
Institut Jules Bordet Brussels
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NOTA-ABSCINT-HER2 PET/CT in people with Metastatic Breast Cancer and Metastatic Solid Cancer, run by Abscint NV/SA at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine Clauwaert (+32476536594, karine.clauwaert@abscint.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.