Malignant Solid TumorPhase 1/2NCT04168528
Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT
A Phase 1/2 study testing 68GaNOTA-Anti-MMR-VHH2 in people with Malignant Solid Tumor and Breast Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2 Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor, Breast Cancer, Melanoma (Skin)
- What is being tested?
- 68GaNOTA-Anti-MMR-VHH2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Nov 2019to 4 Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Patients will only be included in the study if they meet all of the following criteria:
- Patients who have given informed consent
- Patients at least 18 years old
- Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
- Patients will only be included in the study if they meet all of the following criteria:
- Patients who have given informed consent
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- Patients at least 18 years old
- Patients diagnosed with a local, locally advanced or metastatic disease, with any of the following cancer types :
- Triple-negative breast carcinoma,
- Hormone-receptor negative (HR-), HER2+ breast carcinoma, with HER2-expression defined as HER2+ on ISH or 3+ on IHC, as determined by local assessment on any of the available cancer tissues
- Melanoma
- Patients who have had a biopsy of at least one lesion or who are planned to undergo standard-of-care resection or biopsy of at least one lesion, in order to minimize partial volume effect, the diameter of that lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
Who cannot join
- Patients will not be included in the study if one of the following criteria applies:
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Breast feeding patients
- Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
- Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
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- Patients with any serious active infection
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- Patients who cannot communicate reliably with the investigator
- Patients who are unlikely to cooperate with the requirements of the study
- Patients who are unwilling and/or unable to give informed consent
- Patients at increased risk of death from a pre-existing concurrent illness
- Patients who participated already in this study
- PART II:
- Patients will not be included in the study if one of the following criteria applies:
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Breast feeding patients
- Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
- Patients with any serious active infection
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
- Patients who cannot communicate reliably with the investigator
- Patients who are unlikely to cooperate with the requirements of the study
- Patients who are unwilling and/or unable to give informed consent
- Patients at increased risk of death from a pre-existing concurrent illness
- Patients who participated already in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/IIa Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of 68GaNOTA-Anti-MMR-VHH2, a New Radiopharmaceutical for in Vivo Imaging of Tumour-Associated Macrophages by Means of PET : UZBRU_VHH2_1
Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2
Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. To correlate uptake of 68Ga-NOTA-anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion.
- Conditions
- Malignant Solid Tumor, Breast Cancer, Melanoma (Skin)
- Being tested
- 68GaNOTA-Anti-MMR-VHH2
- Keywords
- PET/CT, MMR-PET/CT, Macrophage PET/CT
- Medical subject headings
- Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68GaNOTA-Anti-MMR-VHH2Drug
Injection of the radiopharmaceutical and PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Part I: safety, tolerability, biodistribution and dosimetry | Experimental | Phase I Receives: Drug: 68GaNOTA-Anti-MMR-VHH2 |
| Part II: tumor targeting potential and correlation to IHC | Experimental | Phase II Receives: Drug: 68GaNOTA-Anti-MMR-VHH2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).
Assessed using physical examination and blood sampling for hematology and clinical chemistry.
Measured: Before injection up until 6 hrs after injection
Human biodistribution using blood sampling and PET/CT imaging: reported as relative uptake values per organ at 10, 90 and 150 minutes per individual subject and as a mean over all subjects (Part I).
Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.
Measured: Immediately after injection up to 3 hrs after injection
Human dosimetry using PET/CT imaging data: radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I).
Dosimetry will be calculated using the OLINDA software.
Measured: 10 min up to 3 hrs after injection
Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II).
PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale.
Measured: Resection of lesion up to 14 days after PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start5 Nov 2019
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Why it stopped: Delay in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Tony LAHOUTTE, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168528
- Sponsor's protocol ID
- UZBRU_VHH2_1
- Other IDs
- 2017-001471-23, 2017
- Status last verified
- Dec 2024
- First submitted
- 7 Nov 2019
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of 68GaNOTA-Anti-MMR-VHH2, a New Radiopharmaceutical for in Vivo Imaging of Tumour-Associated Macrophages by Means of PET : UZBRU_VHH2_1
- ClinicalTrials.gov ID
- NCT04168528
- Acronym / sponsor ID
- UZBRU_VHH2_1
- Conditions
- Malignant Solid Tumor, Breast Cancer, Melanoma (Skin)
- Keywords
- PET/CT, MMR-PET/CT, Macrophage PET/CT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Delay in recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 19 Nov 2019 (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.
Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2
Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. To correlate uptake of 68Ga-NOTA-anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part I: safety, tolerability, biodistribution and dosimetry | Experimental | Drug: 68GaNOTA-Anti-MMR-VHH2Phase I |
| Part II: tumor targeting potential and correlation to IHC | Experimental | Drug: 68GaNOTA-Anti-MMR-VHH2Phase II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who have given informed consent
- Patients at least 18 years old
- Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
- Patients who have given informed consent
- Patients at least 18 years old
Key exclusion criteria (26 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Breast feeding patients
- Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
- Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
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 |
|---|---|---|
| 68GaNOTA-Anti-MMR-VHH2Injection of the radiopharmaceutical and PET/CT imaging | Drug | Part I: safety, tolerability, biodistribution and dosimetry, Part II: tumor targeting potential and correlation to IHC |
Primary outcome
Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).
Time frame: Before injection up until 6 hrs after injection
Assessed using physical examination and blood sampling for hematology and clinical chemistry.
Human biodistribution using blood sampling and PET/CT imaging: reported as relative uptake values per organ at 10, 90 and 150 minutes per individual subject and as a mean over all subjects (Part I).
Time frame: Immediately after injection up to 3 hrs after injection
Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.
Human dosimetry using PET/CT imaging data: radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I).
Time frame: 10 min up to 3 hrs after injection
Dosimetry will be calculated using the OLINDA software.
Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II).
Time frame: Resection of lesion up to 14 days after PET/CT
PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale.
Results and safety
The study was stopped early (reason given: Delay in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tony LAHOUTTE, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68GaNOTA-Anti-MMR-VHH2 in people with Malignant Solid Tumor and Breast Cancer, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 12 inclusion and 26 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: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study was stopped early (reason given: Delay in recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I). (time frame: Before injection up until 6 hrs after injection). The study lists 4 primary outcomes in all. 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 1 Jun 2026.