The aim of this study is to assess the safety of \[177Lu\]Lu-OncoFAP-23 alone or in combination with L19-IL2 for the treatment of advanced/metastatic Fibroblast Activation Protein (FAP)-positive solid tumors and to establish a Recommended Dose (RD).
Patients with advanced/metastatic solid tumors, who have progressed on available standard treatments.
Patients with FAP-positive tumors as evaluated by [68Ga]Ga-OncoFAP-DOTAGA-PET/CT imaging.
Patients without other therapeutic alternatives with curative or survival prolonging potential as per investigator judgement.
Male or non-pregnant and non-breast feeding female, age 18 or more.
Any cancer therapy within 4 weeks of study entry.
Active or history of autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent.
Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, Iodine-131, Lutetium-177 conjugates or hemi-body irradiation within 6 months prior to enrollment.
White blood cell count (WBC) minor than 2.5 x 109/L, absolute neutrophil count (ANC) minor than 1.5 x 109/L, platelets minor than 100 x 109/L or hemoglobin (Hb) minor than 9.0 g/dl,
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Treatment groupsSee each treatment group below.
Philogen S.p.A.
Lead sponsor