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

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Criteria

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