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Terminated
NCT06376253
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
Conditions: Ovarian Cancer, Lung Cancer
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 4
Sponsor: Novartis Pharmaceuticals
Location: Novartis Investigative Site Tel Aviv
Summary
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).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06376253). StuddyBuddy aggregates publicly available trial information.