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Trial Title:
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
NCT ID:
NCT06376253
Condition:
Ovarian Cancer
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Ovarian Neoplasms
Conditions: Keywords:
ovarian cancer
non-squamous non-small cell lung cancer (non sq. NSCLC)
advanced solid tumors
radioligand therapy (RLT)
[177Lu]Lu-EVS459
[68Ga]Ga-EVS459
folate receptor (FR)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-EVS459
Description:
Radioligand imaging agent
Arm group label:
Arm1
Intervention type:
Drug
Intervention name:
[177Lu]Lu-EVS459
Description:
Radioligand therapy
Arm group label:
Arm1
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).
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Start date:
September 8, 2024
Completion date:
August 30, 2030
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06376253
