Efficacy and safety of lutetium‑177 vipivotide tetraxetan with gozetotide in patients with progressive adenoid cystic carcinoma of the salivary glands

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What is this study about?

The study examines patients with adenoid cystic carcinoma of the salivary glands, a rare type of cancer that often grows slowly but can spread to other areas. The investigational medicine is a lutetium-177-labeled PSMA ligand, which combines a small amount of radioactive lutetium with a molecule that binds to a protein found on many cancer cells. This medication is administered by IV infusion.

The main aim is to determine whether the treatment can shrink tumors and keep the disease from getting worse. Participants receive a series of treatment sessions about every six weeks, with regular check‑ups and scans to see how the cancer is responding, while any side effects are recorded.

Researchers will use questionnaires to assess quality of life and will perform imaging called scintigraphy after the first and third treatment cycles to measure how much of the medicine reaches the tumor. Safety information is gathered through routine lab tests and vital‑sign checks, and participants are followed for several months to track overall health outcomes.

1 baseline assessments

after joining the study, you will undergo baseline assessments that include a review of your medical history, laboratory tests, imaging studies, and completion of quality of life questionnaires.

these assessments establish a reference point for evaluating the effect of the treatment.

2 first treatment infusion

you will receive an intravenous infusion that contains pluvicto at a dose of 7400 mbq and locametz at a dose of 25 µg.

pluvicto is a radiopharmaceutical that delivers targeted radiation to cancer cells, and locametz is a component used to prepare the radiopharmaceutical mixture.

3 post‑infusion monitoring

following the infusion, you will be monitored for a period of time to check vital signs and to observe any immediate side effects.

medical staff will record any adverse events using standard grading criteria.

4 first follow‑up evaluation

a few weeks after the first infusion, you will undergo a follow‑up evaluation that includes a post‑therapy scintigraphy scan to assess how much of the radiotracer has been taken up by the tumor.

additional laboratory tests and quality of life questionnaires will also be completed.

5 subsequent treatment cycles

additional treatment cycles may be administered according to the study schedule.

each cycle uses the same doses of pluvicto (7400 mbq) and locametz (25 µg) given by intravenous infusion.

after each infusion, the same monitoring and follow‑up procedures as described in steps 3 and 4 will be repeated.

6 final assessments

once the last treatment cycle is completed, you will have a final set of assessments that include imaging, laboratory tests, and quality of life questionnaires.

these final data will be used to evaluate the overall response to the treatment and any long‑term side effects.

Who Can Join the Study?

Sign a written informed consent form, which means you agree to take part after understanding the study.
Finish your last radiotherapy (a type of radiation treatment) at least 6 months before you try to join the study.
Have disease that is still present, has come back, or has spread to distant parts of the body, and you are not a candidate for further surgery called salvage surgery or more radiotherapy; doctors can include you even if a new tissue sample has not been taken, as long as overall tests suggest the cancer is progressing.
Be older than 18 years.
Have a WHO performance status score of 0, 1, or 2, which means you are fully active (0) or able to carry out most daily activities (1‑2) without being bedridden.
Show a positive result for PSMA expression on a 68Ga-PSMA PET/CT scan, meaning the scan lights up more than a normal liver, indicating the cancer cells have the target protein.
Have disease that can be measured on scans according to RECIST 1.1 criteria, which are standard rules doctors use to define tumor size changes.
Have adequate organ function, which includes:
- Bone marrow: neutrophils (a type of white blood cell) more than 1,500 per microliter, platelets (cells that help clot blood) over 150,000, and hemoglobin (the oxygen‑carrying part of blood) above 9 g/dL.
- Liver: bilirubin (a waste product) within normal limits and albumin (a protein made by the liver) above 2.5 g/dL.
- Kidneys: an estimated glomerular filtration rate (eGFR) higher than 50 mL/min, indicating good kidney filtering ability.
If you are a woman who could become pregnant, you must have a negative pregnancy test, use a highly effective method of contraception from the day you join the study until 7 months after the last dose, and you may not donate eggs during that time.
If you are a man who could father a child, you must use a highly effective method of contraception from the day you join the study until 7 months after the last dose, and you may not donate sperm. If your partner could become pregnant, she must also use effective contraception for the same period.

Who Cannot Join the Study?

Being pregnant or breastfeeding.
Not using reliable birth control if you could become pregnant during the study period.
Having cancer that has spread to the brain, the lining of the brain or spinal cord (meningeal metastases), or to the heart.
Having serious other health problems that could make the study riskier or affect the results, such as uncontrolled heart disease (cardiovascular disease), severe infections, major organ failure (organ dysfunction), or mental or brain conditions (psychiatric or cognitive disorders) that prevent you from following study instructions.
Having a blockage in the urinary system (urinary obstruction) or swelling of the kidney caused by urine buildup (hydronephrosis).
Receiving treatment for another type of cancer at the same time.
Having taken medicines that suppress bone‑marrow function (myelosuppressive therapy), radioactive drugs (radioisotope therapy), or drugs that lower the immune system (systemic immunosuppressive therapy) within the past 4 weeks, except for inhaled or local immune‑suppressing medicines, which are allowed.
Having previously been treated with a drug called 177Lutetium‑labeled PSMA.
Being enrolled in another clinical trial that uses an experimental medicine (investigational medicinal product) and not having waited the required time for that medicine to leave your body (washout period).

Where you can join this trial?

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Site Name	City	Country	Status
Nmdegyft Ibyscmyv Oyahiwctd Iqj Mmmsd Smiyrjkehktwzqdlrl Pzjxlsvrz Imxcsrbh Bxentgjy	Gliwice	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	01.09.2026

Trial locations

Investigated Drugs:

Pluvicto is a medication that contains a radioactive form of lutetium attached to a molecule that seeks out PSMA, a protein often found on certain cancer cells. In this trial, it is given by an IV infusion and is intended to deliver targeted radiation directly to the tumor, helping to stop its growth. The goal is to see how well this treatment works and how safe it is for patients with adenoid cystic carcinoma that has spread from the salivary glands.

Locametz is a kit used to prepare a radiopharmaceutical that includes the substance gozetotide. This agent also targets PSMA but is used mainly for imaging purposes, allowing doctors to see where the cancer cells are located in the body. In the study, it serves as a background reference to help assess the effects of the main treatment.

Investigated Diseases:

Adenoid cystic carcinoma of salivary gland

Adenoid cystic carcinoma of the salivary glands – Adenoid cystic carcinoma of the salivary glands is a cancer that originates in the secretory glands of the mouth and throat. It typically grows slowly but has a tendency to spread along nerves and to distant sites such as the lungs. The tumor may appear as solid, cribriform, or tubular growths, causing swelling or pain in the affected area. Over time it can infiltrate surrounding tissues and may recur after removal. The disease can progress without obvious symptoms until it reaches a more advanced local or metastatic stage.

Trial ID:

2026-525776-26-00

Protocol code:

LURM

Trial Phase:

Therapeutic exploratory (Phase II)

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Efficacy and safety of lutetium‑177 vipivotide tetraxetan with gozetotide in patients with progressive adenoid cystic carcinoma of the salivary glands

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?