Study Description
The purpose of the study is to test the safety and dosing of [177Lu]Lu-FF58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). The study will also further characterize the radioligand imaging agent [68Ga]Ga-FF58 including its ability to identify tumor lesions and its safety profile.
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 be screened with a [68Ga]Ga-FF58 positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan to assess eligibility for treatment with [177Lu]Lu-FF58. In the escalation part, different doses of [177Lu]Lu-FF58 will be tested to identify the recommended dose. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-FF58 at the recommended dose 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, or the study is terminated early in which case all patients would also be followed up for safety.
Interventions
177Lu-FF58
68Ga-FF58
Eligibility Criteria
Key Inclusion criteria
Age >= 18 years old
Patients with locally advanced unresectable or metastatic PDAC, locally advanced unresectable or metastatic GEA, or recurrent GBM
To be treated with [177Lu]Lu-FF58, patients must have at least one measurable lesion that shows [68Ga]Ga-FF58 uptake on PET/CT or PET/MRI
Key Exclusion criteria
Absolute neutrophil count (ANC) < 1.5 x 109/L, hemoglobin < 10 g/dL, or platelet count < 100 x 109/L
Prior external beam radiation therapy (EBRT) to > 25% of the bone marrow
Creatinine clearance < 60 mL/min
Unmanageable bladder outflow obstruction or urinary incontinence
Non-GBM patients: Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids within 1 week before [177Lu]Lu-FF58 administration
Other protocol-defined inclusion/exclusion criteria may apply
Study Location
Novartis Investigative Site
Recruiting
Tel Aviv,6423906,Israel
Novartis Investigative Site
Recruiting
Nijmegen,Netherland,6525 GA,Netherlands
Novartis Investigative Site
Recruiting
Hospitalet de LLobregat,Catalunya,08907,Spain
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Geneve 14,CH 1211,Switzerland
Worldwide Contacts
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