TheranosticTrials.org

Clinical Trial · NCT06376253

A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers

Overview

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC).

Sponsor

Novartis

Phase

Phase 1

ClinicalTrials.gov

NCT06376253

Drug / Compound

EVS459

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

EVS459

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

Eligibility

Inclusion

  • Patients with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (non sq. NSCLC) with disease progression following, or intolerance to, at least 1 line of therapyKey

Exclusion

  • QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
  • Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-EVS459Other protocol-defined inclusion/exclusion criteria may apply.
  • Creatinine clearance \< 60 mL/min
  • Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, hemoglobin \< 10 g/dL, or platelet count \< 100 x 10\^9/L
  • Unmanageable urinary tract obstruction or urinary incontinence