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

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.

• Lutetium (177Lu) vipivotide tetraxetan (Drug), also known as Pluvicto 1 000 MBq/mL: 6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks

Primary outcomes

• Assessment of the effectiveness of the study treatment [2 years after the end of treatment]: Objective response rate (ORR) - RECIST 1.1 score in CT examination 2 years after completion of treatment

Secondary outcomes

• Assessment of the effectiveness of the study treatment [Time from the date of initiation of the treatment to the disease progression or death]: Progression free survival
• Assessment of the effectiveness of the study treatment [Time from the date of initiation of the treatment to death]: Overall survival
• Assessment of the effectiveness of the study treatment [Time from the date of initiation of the treatment to the disease progression or death]: Duration of response
• Assessment of quality of life [Time from the the date of initiation of treatment to the disease progression or death]: Assessment of quality of life (according to the EORTC QLQ-C30 and EORTC QLQ-H\&N43 questionnaire)
• Assessment of safety and tolerance [Time from the date of initiation of the treatment to disease progression or death]: Assessment of safety and tolerance of treatment according to Common Terminology Criteria for Adverse Events v. 5.0

Sex: All, ages: 18 Years to any

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