TheranosticTrials.org

Clinical Trial · NCT06531499

A Study of Radiation Dosimetry, Safety, and Tolerability of Extended Lutetium (177Lu) Vipivotide Tetraxetan Treatment in Chemo-naïve Adults With Metastatic Castration-resistant Prostate Cancer: RADIOpharmaceutical DOSimetry Evaluation (RADIODOSE) Study

Overview

The purpose of the study is to assess and evaluate dosimetry, safety, and tolerability following administration of up to 12 cycles of (177Lu) vipivotide tetraxetan (also referred to as \[177Lu\]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter identified as AAA617) in taxane-naïve adult participants with PSMA-positive mCRPC who progressed on a prior ARPI treatment with normal renal function or mild renal impairment (eGFR ≥ 60ml/min).

Sponsor

Novartis

Phase

Phase 1

Contacts

Novartis Pharmaceuticals (CONTACT)

novartis.email@novartis.com

1-888-669-6682

Novartis Pharmaceuticals (STUDY_DIRECTOR)

Novartis Pharmaceuticals (CONTACT)

+41613241111

ClinicalTrials.gov

NCT06531499

Drug / Compound

PSMA-617

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

Eligibility

Inclusion

  • Participants must have an ECOG performance status ≤ 1.
  • Participants must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies except alopecia.Key
  • Documented progressive mCRPC
  • Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L) either by pharmaceutical or surgical methods.
  • Participants must have histological confirmation of adenocarcinoma of the prostate.
  • Participants must have progressed only once on prior second generation ARPIs
  • Renal: eGFR ≥ 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Participants must have ≥ 1 metastatic lesion by conventional imaging that is present on screening/baseline CT, MRI, or bone scan
  • Participants must be PSMA-positive per 68Ga-PSMA PET/CT scans at baseline

Exclusion

  • History of somatic or psychiatric disease/condition that may interfere with the aims and assessments of the study.Other protocol-defined inclusion/exclusion criteria may apply.
  • Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment
  • Prior treatment with cytotoxic chemotherapy for metastatic castration-resistant or metastatic hormone-sensitive prostate cancer (mHSPC) (e.g., taxanes, platinum, estramustine, vincristine, methotrexate, etc.), immunotherapy or biological therapy \[including monoclonal antibodies\]. \[Note: Taxane exposure (maximum 6 cycles) in the adjuvant or neoadjuvant setting is allowed if 12 months have elapsed since completion of this adjuvant or neoadjuvant therapy. Prior treatment with sipuleucel-T is allowed\].
  • Any previous radioligand therapy.
  • Previous treatment with any of the following within 6 months of study enrollment: Strontium 89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation
  • Concurrent therapies: cytotoxic chemotherapy, immunotherapy, radioligand therapy, PARP inhibitor, biological, or investigational therapy
  • Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 14 weeks after stopping study treatment.
  • Concurrent urinary outflow obstruction or unmanageable urinary incontinence
  • Concurrent serious acute or chronic nephropathy and/or moderate to severe renal impairment as determined by the principal investigator.