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

Trial ID or NCT#

NCT06376253

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers

Eligibility Criteria

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * Age \>= 18 years old* 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 therapy
    1. Key
Exclusion Criteria:
  1. * Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, hemoglobin \< 10 g/dL, or platelet count \< 100 x 10\^9/L* QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec* Creatinine clearance \< 60 mL/min* Unmanageable urinary tract obstruction or urinary incontinence* Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-EVS459
    1. Other protocol-defined inclusion/exclusion criteria may apply.
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Investigator(s)

Kip E. Guja, MD PhD
Clinical Instructor, Radiology - Rad/Nuclear Medicine

View on ClinicalTrials.gov