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

NCT06199453 | Withdrawn Phase 2 DMC

• 2 other identifiers: LuRM_ACC/2023EU CT 2023-504699-73-00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (1)

• Assessment of the effectiveness of the study 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 Outcomes (5)

• Assessment of the effectiveness of the study treatment

  Time from the date of initiation of the treatment to the disease progression or death

• Assessment of the effectiveness of the study treatment

  Time from the date of initiation of the treatment to death

• Assessment of the effectiveness of the study treatment

  Time from the date of initiation of the treatment to the disease progression or death

• Assessment of quality of life

  Time from the the date of initiation of treatment to the disease progression or death

• Assessment of safety and tolerance

  Time from the date of initiation of the treatment to disease progression or death

Study Arms (1)

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

Interventions

Lutetium (177Lu) vipivotide tetraxetan DRUG

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

Also known as: Pluvicto 1 000 MBq/mL

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie National Research Institute of Oncology

Gliwice, 44-102, Poland

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Lutetium; Lutetium-177

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)