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

Recruiting

Trial ID: NCT06376253

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

Stanford Investigator(s)

Jagruti Shah

Clinical Associate Professor, Radiology - Rad/Nuclear Medicine

Kip E. Guja, MD PhD

Clinical Assistant Professor, Radiology - Rad/Nuclear Medicine

Eligibility

Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Other protocol-defined inclusion/exclusion criteria may apply.

Intervention(s):

drug: [68Ga]Ga-EVS459

drug: [177Lu]Lu-EVS459

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305