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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06376253.
The study will be done in two parts. The first part is called "escalation" and the second
part is called "expansion". In both parts of the study, patients will initially be imaged
with a [68Ga]Ga EVS459 positron emission tomography (PET)/computed tomography (CT) or
PET/magnetic resonance imaging (MRI) scan. In the escalation part, different doses of
[177Lu]Lu-EVS459 will then be tested to identify recommended dose(s) (RD(s)) for further
evaluation. The expansion part of the study will examine the safety and preliminary
efficacy of [177Lu]Lu-EVS459 at the RD(s) determined during the escalation part. The end
of study will occur when at least 80% of the patients in the expansion part have
completed the follow-up for disease progression or discontinued from the study for any
reason, and all patients have completed treatment and the 36-month long-term follow-up
period.
Lead OrganizationNovartis Pharmaceuticals Corporation
