phase i/iia study of 68ganota-anti-mmr-vhh2 for pet/ct

Conditions: Malignant Solid Tumor; Breast Cancer; Melanoma (Skin)

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. to correlate uptake of 68ga-nota-anti-mmr-vhh2 in cancer lesions to immunohistological mmr staining after resection or biopsy of the same lesion.


Eligibility criteria:
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

Keywords: pet/ct mmr-pet/ct macrophage pet/ct