Clinical trial · Interventional
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative reasons
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoid Cystic Carcinoma | Adenoid Cystic Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lutetium (177Lu) vipivotide tetraxetan | Drug | Lutetium (177lu) Vipivotide Tetraxetan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 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.
- interventionNames
- Drug: Lutetium (177Lu) vipivotide tetraxetan
Primary outcomes (1)
- measure
- Assessment of the effectiveness of the study treatment
- timeFrame
- 2 years after the end of treatment
- description
- Objective response rate (ORR) - RECIST 1.1 score in CT examination 2 years after completion of treatment
Secondary outcomes (5)
- measure
- Assessment of the effectiveness of the study treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available