A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.
Pancreatic Ductal Adenocarcinoma, Gastroesophageal Adenocarcinoma, Glioblastoma Multiforme
About this trial
This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring pancreatic ductal adenocarcinoma, PDAC, pancreatic cancer, gastroesophageal adenocarcinoma, GEA, gastric cancer, gastric adenocarcinoma, esophageal cancer, esophageal adenocarcinoma, glioblastoma multiforme, GBM, advanced solid tumors, radioligand therapy, RLT, [177Lu]Lu-FF58, [68Ga]Ga-FF58, integrins, alpha-v beta-3 integrin, αvβ3, alpha-v beta-5 integrin, αvβ5
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
Sites / Locations
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Experimental
Arm 1
Patients will receive 68Ga-FF58 and only patients with tumor uptake of 68Ga-FF58 will receive 177Lu-FF58.