Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT

Trial details

Who runs it

Universitair Ziekenhuis Brussel

Trial code

NCT04168528

Record updated

1 June 2026

Original description

Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2Read full original descriptionShow less

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.

Inclusion: 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; 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: Patients at increased risk of death from a pre-existing concurrent illness; Patients at increased risk of death from a pre-existing concurrent illness; 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 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 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 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 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 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 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 who participated already in this study.

PART I:.

ClinicalTrials.gov NCT04168528