177Lu-PSMA (177Lu-PNT2002) in PSMA-Positive Adenoid Cystic Carcinoma

Stopped early · Phase 2

Conditions studied: Adenoid Cystic Carcinoma

In brief

This is a single arm trial with one Cohort for people with recurrent or metastatic adenoid cystic carcinoma that cannot be treated with surgery. 10 participants will be enrolled in Cohort 1 at Johns Hopkins and will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). A feasibility analysis of dosimetry will be performed after meeting the accrual goal of Cohort 1 to determine if the study will proceed into Cohort 2. If Cohort 2 proceeds, based on the dosimetry analysis, the major requirements of the study are to undergo treatment with 177Lu-PNT2002, have bloodwork, physical exams, and imaging done at study-specific time points, and to answer questionnaires. Patients will be in the study for about two years after enrolling.

Key facts

Study ID: NCT06322576
Run by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
People needed: 1
Starts: 2025-02-10
Expected to finish: 2026-01-20
Last updated by the study team: 2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologic confirmation of ACC (primary or metastatic tumor). Central review not required but local pathology review required (at Johns Hopkins or Stanford).
Patients must have recurrent or metastatic ACC with measurable disease per RECIST 1.1, not amenable to definitive surgery or radiotherapy.
Patients must have at least 1 lesion positive on PSMA-PET, as defined by standard uptake value (SUV) ratio of tumor to liver greater than one.
Patient can have any or no prior systemic therapies.
At least 28 days must have elapsed between last anti-cancer treatment administration and the initiation of study treatment, or at least 5 half-lives of the prior systemic therapy must have elapsed (whichever is shorter).
Patient must have resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤ 2.
Patient must be ≥ 18 years of age.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
For female patients with childbearing potential or male patients with partners of childbearing potential, agreement to use barrier contraceptive method (condom) and to continue its use for 6 months from receiving the last dose of 177Lu-PSMA. Female patients with childbearing potential will undergo a urine pregnancy test. Pregnant female participants are excluded.
Patient must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

Spinal cord compression or impending spinal cord compression.
Suspected pulmonary and/or liver metastases (greater >10 mm in largest axis).
Unable to lie flat during or tolerate PET/CT.
Refusal to sign informed consent.
Any medical comorbidities that might preclude safe participation in the study.
Additional inclusion criteria only relevant if Cohort 2 participants enrolled:
Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 28 days demonstrating:
Platelet count of >100 x109/L
White blood cell (WBC) count > 3,000/mL
Neutrophil count of > 1,500/mL
Hemoglobin ≥ 10 g/dL
Estimated glomerular filtration rate (eGFR) > 50 mL/min based upon Chronic Kidney Disease- Epidemiology Collaboration (CKD-EPI) equation. Due to safety concerns relating to renal clearance and toxicity of 177Lu-PSMA, patients with estimated GFR between 50 - 60 mL/min will require a 99mTc-TPA GFR test and only patients with non-obstructive pathology will be included in the study.
Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN), total bilirubin < 3 x ULN
Total bilirubin < 3 x ULN (except if confirmed history of Gilbert's disease)
Serum albumin > 30 g/L
Additional exclusion criteria only relevant if Cohort 2 participants enrolled:
Inadequate bone marrow reserve and organ function as detailed in eligibility criteria.
Patient is participating in a concurrent investigative treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.
Patient receiving any other investigational agents.

Where it is running

Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.