Clinical trial · Interventional
Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT
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
NCT04168528CI-TRIAL-00113065terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Delay in recruitment
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68GaNOTA-Anti-MMR-VHH2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part I: safety, tolerability, biodistribution and dosimetry
- description
- Phase I
- interventionNames
- Drug: 68GaNOTA-Anti-MMR-VHH2
- type
- EXPERIMENTAL
- label
- Part II: tumor targeting potential and correlation to IHC
- description
- Phase II
- interventionNames
- Drug: 68GaNOTA-Anti-MMR-VHH2
Primary outcomes (4)
- measure
- Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).
- timeFrame
- Before injection up until 6 hrs after injection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
PART I: Inclusion Criteria: 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. Exclusion Criteria: 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 * 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: Inclusion Criteria: 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 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. Exclusion Criteria: 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
References
Publications (0)
Data not yet available
No reference posted for this study.