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

Novartis

Status and phase: Active, not recruiting; Phase 1

Conditions: Lung Cancer; Ovarian Cancer

Treatments: Drug: [177Lu]Lu-EVS459; Drug: [68Ga]Ga-EVS459

Study type: Interventional

Funder types: Industry

Identifiers

NCT06376253

2023-507674-41-00 (Other Identifier)

CGIZ943A12101

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Arm1

Experimental group

Description:

Patients will receive \[68Ga\]Ga-EVS459 and, if eligible, \[177Lu\]Lu-EVS459

Treatment:

Drug: [68Ga]Ga-EVS459

Drug: [177Lu]Lu-EVS459