NCT06322576

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

A Phase 2, Single-Arm, Multi-center Study of 177Lu-PSMA (177Lu-PNT2002) in Patients With PSMA-Positive Adenoid Cystic Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Malignant salivary gland tumors account for approximately 3% to 5% of all head and neck cancers with approximately 0.4 to 2.6 cases per 100,000 people. Most patients present in the sixth to seventh decade of life. Adenoid cystic carcinoma (ACC) accounts for about 10% of all tumors of the salivary glands, often arises from the minor and major salivary glands but can also involve lacrimal and ceruminous glands, as well as other sites in the head and neck (nasal and paranasal sinuses, trachea, and larynx). Anatomically, ACC originates from the intercalated duct region and proliferates in three distinct architectural patterns: tubular, cribriform, and solid. In the setting of recurrent and metastatic (R/M) ACC, first-line options include single-agent vinorelbine or mitoxantrone, or cyclophosphamide plus doxorubicin plus cisplatin (CAP). Overall response rates (ORR) are usually less than 15%. There are no effective second line options. While epidermal growth factor receptor (EGFR) has been shown to be overexpressed in some ACC, none of the phase II clinical trials of single agent cetuximab, gefitinib, or lapatinib demonstrated an objective response. Many cases of ACC also express the c-kit protein, however, use of single agent imatinib in patients with c-kit expression confirmed by immunohistochemistry (IHC) failed to produce an objective response. Phase II single agent sunitinib exhibited no objective response. Median progression free survival (PFS) of these phase II trials ranged from 3.5 months to 7.2 months. Ultimately, most patients with R/M ACC die from cancer, highlighting the need for effective therapies. The investigators aim to examine and analyze PSMA-PET uptake in ACC to establish whether it is correlated to absorbed tumor dose and objective response in Cohort 1 participants.

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-11-16
• Completion: 2026-01-20
• First posted: 2024-03-21
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study