Adenoid Cystic CarcinomaPhase 2LuRM_ACC/2023NCT06199453
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial
A Phase 2 study testing Lutetium (177Lu) vipivotide tetraxetan in people with Adenoid Cystic Carcinoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma
- What is being tested?
- Lutetium (177Lu) vipivotide tetraxetan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2024to Nov 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, 44-102
About this study
Official title: 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.
Read the 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
- Being tested
- Lutetium (177Lu) vipivotide tetraxetan
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium (177Lu) vipivotide tetraxetanDrug
Also called Pluvicto 1 000 MBq/mL
6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lutetium (177Lu) vipivotide tetraxetan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after the end of treatment
Secondary outcomes (5)
Assessment of the effectiveness of the study treatment
Progression free survival
Measured: Time from the date of initiation of the treatment to the disease progression or death
Assessment of the effectiveness of the study treatment
Overall survival
Measured: Time from the date of initiation of the treatment to death
Assessment of the effectiveness of the study treatment
Duration of response
Measured: Time from the date of initiation of the treatment to the disease progression or death
Assessment of quality of life
Assessment of quality of life (according to the EORTC QLQ-C30 and EORTC QLQ-H\&N43 questionnaire)
Measured: Time from the the date of initiation of treatment to the disease progression or death
Assessment of safety and tolerance
Assessment of safety and tolerance of treatment according to Common Terminology Criteria for Adverse Events v. 5.0
Measured: Time from the date of initiation of the treatment to disease progression or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199453
- Sponsor's protocol ID
- LuRM_ACC/2023
- Other IDs
- EU CT 2023-504699-73-00
- Acronym
- LuRM_ACC/2023
- Status last verified
- Feb 2025
- First submitted
- 29 Dec 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06199453
- Acronym / sponsor ID
- LuRM_ACC/2023 / LuRM_ACC/2023
- Conditions
- Adenoid Cystic Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Lutetium (177Lu) vipivotide tetraxetanTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutetium (177Lu) vipivotide tetraxetanAlso: Pluvicto 1 000 MBq/mL6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks | Drug | Experimental |
Primary outcome
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
5 secondary outcomes
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
Assessment of the effectiveness of the study treatment
Time frame: 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
Assessment of quality of life
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lutetium (177Lu) vipivotide tetraxetan in people with Adenoid Cystic Carcinoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effectiveness of the study treatment (time frame: 2 years after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.