The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial (LuRM_ACC/2023)

February 6, 2025 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gliwice, Poland, 44-102
        • Maria Sklodowska-Curie National Research Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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
Other Names:
  • Pluvicto 1 000 MBq/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the effectiveness of the study treatment
Time Frame: 2 years after the end of treatment
Objective response rate (ORR) - RECIST 1.1 score in CT examination 2 years after completion of treatment
2 years after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the effectiveness of the study treatment
Time Frame: Time from the date of initiation of the treatment to the disease progression or death
Progression free survival
Time from the date of initiation of the treatment to the disease progression or death
Assessment of the effectiveness of the study treatment
Time Frame: Time from the date of initiation of the treatment to death
Overall survival
Time from the date of initiation of the treatment to death
Assessment of the effectiveness of the study treatment
Time Frame: Time from the date of initiation of the treatment to the disease progression or death
Duration of response
Time from the date of initiation of the treatment to the disease progression or death
Assessment of quality of life
Time Frame: 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)
Time from the the date of initiation of treatment to the disease progression or death
Assessment of safety and tolerance
Time Frame: 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
Time from the date of initiation of the treatment to disease progression or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

December 29, 2023

First Submitted That Met QC Criteria

December 29, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LuRM_ACC/2023
  • EU CT 2023-504699-73-00 (Other Identifier: EMA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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