Tumour associated macrophages found in tumour lesions of two cancer types: breast cancer or melanoma
Conditions
Interventions
Product Name: 68GaNOTA-Anti-MMR-VHH2
Pharmaceutical Form: Solution for injection
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part I 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 - Patient 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. Part II 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: o Triple-negative breast carcinoma o 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 o 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: Part I 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part I: To evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2 Part II: 1. To evaluate tumour uptake of 68GaNOTA-Anti-MMR-VHH2 in patients with breast cancer or melanoma. 2. To correlate uptake of 68GaNOTA-Anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion. ;Secondary Objective: Part I: To evaluate tumour uptake of 68GaNOTA-Anti-MMR-VHH2 in patients with malignant solid tumour and compare to immunohistological MMR staining after resection of a lesion if available ;Primary end point(s): Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2 via clinical and laboratory assessments. Human biodistribution and dosimetry via blood sampling for blood curves, via PET imaging for organ uptake and dosimetry. Tumour targeting potential via uptake values on PET imaging, and correlation to immunohistological MMR staining;Timepoint(s) of evaluation of this end point: Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2, human biodistribution and dosimetry after completion of part I (6 study patients) Tumour targeting potential and correlation to immunohistological MMR staining: after completion of part II (total of 31 study patients) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactTony Lahoutte
UZ Brussel
Outcome results
None listed