The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial

The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a Specialized Prostate-specific Membrane Antigen (PSMA) Labeled with Lutetium177, in Patients with Recurrent And/or Metastatic Adenoid Cystic Carcinoma Originating from the Salivary Glands - an Open, Non-commercial Clinical Trial

Non-commercial phase 2 clinical trial to evaluate the effectiveness, safety and tolerability of treatment using prostate-specific membrane antigen (PSMA) labeled with 177Lutetium in patients with recurrence and/or metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region.

Patients with PSMA receptor expression confirmed by PET/CT after administration of 68Ga-PSMA I&T will be eligible for treatment.

It is planned to enroll 32 patients diagnosed with non-resectable recurrence and/or dissemination in the course of ACC, whose general condition and life expectancy justify qualification for diagnosis using PSMA 68Ga and treatment with lutetium (177Lu) vipivotide-tetraxetan

The Study assumes the administration of 6 cycles of treatment (lutetium [177Lu] vipivotide-tetraxetan) at 6-week intervals.

If toxicity occurs, the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks.

After completing 6 cycles of therapy, the participant enters the observation phase, which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy.

Inclusion criteria:

• Signing the informed consent form to participate in the study
• Patients with inoperable, locoregionally advanced or metastatic, histopathologically confirmed adenoid cystic carcinoma of salivary gland
• Age over 18 years
• WHO performance status 0 to 2
• PSMA expression confirmed by PET/CT using 68Ga-PSMA;
• Presence of measurable disease according to RECIST 1.1 criteria
• Adequate function of: bone marrow, liver, kidneys:

bone marrow: neutrophils >1500x10^9/L; thrombocytes >150,000x10^9/L, hemoglobin >9 g/dl liver: bilirubin <2xULN; aminotransferases <3xULN (in patients with liver metastases <5xULN) kidney: eGFR >50 ml/min albumin >2.5 mg/ml

• For women of reproductive age: confirmed negative pregnancy test
• The need to use of a highly effective method of contraception

Exclusion criteria:

• Pregnancy or breastfeeding
• Lack of effective contraception during childbearing age
• Patients with metastases to the brain, meninges or heart
• Severe or significant additional diseases in the opinion of the investigator
• Urinary tract obstruction and/or hydronephrosis.
• Concomitant treatment of another cancer
• Myelosuppressive or nuclear treatment later than 4 weeks after qualification
• Previous treatment with 177Lutetium-labeled PSMA