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

NCT ID: NCT06199453

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2027-11-30

Brief 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.

Detailed Description

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.

Conditions

Adenoid Cystic Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Treatment will consist of administration of 6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks.

Group Type: EXPERIMENTAL

Lutetium (177Lu) vipivotide tetraxetan

Intervention Type: DRUG

6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks

Interventions

Lutetium (177Lu) vipivotide tetraxetan

6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks

Intervention Type: DRUG

Other Intervention Names

Pluvicto 1 000 MBq/mL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maria Sklodowska-Curie National Research Institute of Oncology

Gliwice, , Poland

Countries

Poland

Other Identifiers

EU CT 2023-504699-73-00

Identifier Type: OTHER

Identifier Source: secondary_id

LuRM_ACC/2023

Identifier Type: -

Identifier Source: org_study_id