A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.

• Status: Recruiting
• Trial end date: 2026-04-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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