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

NCT06322576 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-01-22

No results posted yet for this study

Summary

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.

Conditions

  • Adenoid Cystic Carcinoma

Interventions

DRUG

177Lu-PNT2002

10 patients will undergo DCFPyL PET/CT and 177Lu-PSMA dosimetry imaging only (single tracer dose). If opened, Cohort 2 patients will receive 4 cycles, every 8 weeks of 177Lu-PSMA infusion. Other procedures during treatment and follow up may include: physical exam, CT/MRI, PSMA-PET, blood draws, adverse event assessment, and completion of questionnaires.

Sponsors & Collaborators

  • Adenoid Cystic Carcinoma Research Foundation

    collaborator OTHER

  • Progenics Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Ana Kiess, MD, PhD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-11-16
Completion
2026-01-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06322576 on ClinicalTrials.gov