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

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