Clinical Trial Finder

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

Arms

Experimental: Part I: safety, tolerability, biodistribution and dosimetry

Phase I

Experimental: Part II: tumor targeting potential and correlation to IHC

Phase II

Interventions

Drug: - 68GaNOTA-Anti-MMR-VHH2

Injection of the radiopharmaceutical and PET/CT imaging