TheranosticTrials.org

Clinical Trial · NCT06379217

NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

Overview

The purpose of this study is to evaluate the change in the expression of treatment targets on the surface of tumor cells (Prostate Specific Membrane Antigen (PSMA), Somatostatin Receptor 2 (SSTR2), and Gastrin Releasing Peptide Receptor (GRPR) between the baseline and following targeted radioligand therapy (RLT). Study will use radioligand imaging (RLI) to determine predominantly expressed target on the surface of tumor cells. Based on predominant expression of target, corresponding RLT targeting PSMA, SSTR2, or GRPR RLT will be given for up to 6 cycles every 6 weeks as intravenous (i.v.) injection in participants with metastatic neuroendocrine prostate cancer (mNEPC).

Sponsor

Novartis

Phase

Phase 1

Contacts

Novartis Pharmaceuticals (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT06379217

Drug / Compound

DOTA-TATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

NeoB

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

NeoB

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

DOTA-TATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

NeoB

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: DOTA

DOTA-TATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

PSMA-617

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

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

PSMA-617

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

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

DOTA-TATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

NeoB

Isotope(s):
Target(s):
  • GRPR
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Serum chromogranin A \> 5x normal limit, or neuron-specific enolase \> 2x normal limit with control for proton-pump inhibitors (PPI) drugs among concomitant treatment
  • Histologically small cell or neuroendocrine cancer from a primary prostate or metastatic biopsy confirmed by local laboratory.
  • Expression of NEPC markers (e.g., chromogranin or synaptophysin) in tumor tissue by IHC confirmed by local laboratory
  • * Participants must have metastatic prostate cancer with neuroendocrine differentiation as determined by at least one of the following:
  • Progression of visceral metastases in the absence of PSA progression

Exclusion

  • * Previous treatment with any of the following within 6 months prior to Screening: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
  • History of CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity
  • Previous PSMA, SSTR2, or GRPR targeted radioligand therapy
  • Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy or investigational therapy
  • Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression