TheranosticTrials.org

Clinical Trial · NCT06322576

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

Overview

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.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 2

Contacts

Ana Kiess, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT06322576

Drug / Compound

DCFPyL

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

PNT2002

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • 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.
  • Histologic confirmation of ACC (primary or metastatic tumor). Central review not required but local pathology review required (at Johns Hopkins or Stanford).
  • Patient must have resolution of all previous treatment related toxicities to CTCAE version 5.0 grade of ≤ 2.
  • Patients must have recurrent or metastatic ACC with measurable disease per RECIST 1.1, not amenable to definitive surgery or radiotherapy.
  • 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).

Exclusion

  • Neutrophil count of \> 1,500/mL
  • Hemoglobin ≥ 10 g/dL
  • Any medical comorbidities that might preclude safe participation in the study.Additional inclusion criteria only relevant if Cohort 2 participants enrolled:
  • Serum albumin \> 30 g/LAdditional exclusion criteria only relevant if Cohort 2 participants enrolled:
  • Platelet count of \>100 x109/L
  • Spinal cord compression or impending spinal cord compression.
  • 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.
  • Patient is participating in a concurrent investigative treatment protocol involving radiotherapy, surgery, or systemic anti-cancer agents.
  • Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤5 x upper limit of normal (ULN), total bilirubin \< 3 x ULN
  • Adequate bone marrow reserve and organ function as demonstrated by complete blood count and chemistry panel completed within the prior 28 days demonstrating:
  • White blood cell (WBC) count \> 3,000/mL
  • Inadequate bone marrow reserve and organ function as detailed in eligibility criteria.
  • Suspected pulmonary and/or liver metastases (greater \>10 mm in largest axis).
  • Total bilirubin \< 3 x ULN (except if confirmed history of Gilbert's disease)
  • Patient receiving any other investigational agents.
  • Unable to lie flat during or tolerate PET/CT.