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

NCT06322576 | Terminated Phase 2 FDA Drug

• 1 other identifier: IRB00347750
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lutetium-177

Outcome Measures

Primary Outcomes (2)

• Absorbed dose in tumor and normal organs

  Objective is to measure absorbed dose in tumor and normal organs using SPECT/CT dosimetry (Cohort 1)

  One dose during one day

• Objective response rate (ORR) by RECIST 1.1 measured in patients treated with 177Lu-PSMA for recurrent and metastatic ACC.

  Only relevant for Cohort 2 patients: Measure response rate (ORR) by RECIST 1.1 in participants treated with 177Lu-PSMA for recurrent and metastatic ACC.

  Pre-treatment, 6 months post treatment

Secondary Outcomes (6)

• Stability of Disease: Proportion of patients with Stable Disease

  6 months post treatment

• Progression Free Survival

  24 months after Day 1, Cycle 1 of treatment (each cycle is 8 weeks)

• Overall Survival

  24 months after Day 1, Cycle 1 of treatment (each cycle is 8 weeks)

• Duration of Response

  24 months after Day 1 of treatment

• Xerostomia questionnaire (XQ) score

  24 months after Day 1 of treatment

Study Arms (1)

SPECT CT Dosimetry

EXPERIMENTAL

Absorbed dose in tumor and normal organs will by measured using SPECT/CT dosimetry in Cohort 1.

Drug: 177Lu-PNT2002

Interventions

177Lu-PNT2002 DRUG

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.

Also known as: 177Lu PSMA

SPECT CT Dosimetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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
• Inadequate bone marrow reserve and organ function as detailed in eligibility criteria.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Adenoid Cystic Carcinoma Research Foundation: collaborator
• Progenics Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (4)

• Seifert R, Kessel K, Schlack K, Weckesser M, Bogemann M, Rahbar K. Radioligand therapy using [177Lu]Lu-PSMA-617 in mCRPC: a pre-VISION single-center analysis. Eur J Nucl Med Mol Imaging. 2020 Aug;47(9):2106-2112. doi: 10.1007/s00259-020-04703-3. Epub 2020 Feb 16.

  PMID: 32062682 BACKGROUND

• von Eyben FE, Roviello G, Kiljunen T, Uprimny C, Virgolini I, Kairemo K, Joensuu T. Third-line treatment and 177Lu-PSMA radioligand therapy of metastatic castration-resistant prostate cancer: a systematic review. Eur J Nucl Med Mol Imaging. 2018 Mar;45(3):496-508. doi: 10.1007/s00259-017-3895-x. Epub 2017 Dec 16.

  PMID: 29247284 BACKGROUND

• Rahbar K, Schmidt M, Heinzel A, Eppard E, Bode A, Yordanova A, Claesener M, Ahmadzadehfar H. Response and Tolerability of a Single Dose of 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer: A Multicenter Retrospective Analysis. J Nucl Med. 2016 Sep;57(9):1334-8. doi: 10.2967/jnumed.116.173757. Epub 2016 Apr 7.

  PMID: 27056618 BACKGROUND

• van Boxtel W, Lutje S, van Engen-van Grunsven ICH, Verhaegh GW, Schalken JA, Jonker MA, Nagarajah J, Gotthardt M, van Herpen CML. 68Ga-PSMA-HBED-CC PET/CT imaging for adenoid cystic carcinoma and salivary duct carcinoma: a phase 2 imaging study. Theranostics. 2020 Jan 12;10(5):2273-2283. doi: 10.7150/thno.38501. eCollection 2020.

  PMID: 32089741 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ana Kiess, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort 1of this study involves only Dosimetry for (10 patients). (Cohort 2 may be added based on dosimetry analysis of Cohort 1. Planned Treatment for would be for 20 patients, single arm).

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 21, 2024
• Study Start: February 10, 2025
• Primary Completion: November 16, 2025
• Study Completion: January 20, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)