This trial aims to address unmet medical needs in advanced solid tumors, specifically metastatic clear cell renal carcinoma, locally advanced or metastatic pancreatic adenocarcinoma, and metastatic colorectal adenocarcinoma.
at least one prior line containing FOLFIRINOX and/or gemcitabine plus nab-paclitaxel, and
at least one approved second-line regimen (e.g., 5-FU/leucovorin plus liposomal irinotecan), or where these regimens are not suitable due to contraindication or prior intolerance
at least one prior line of systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan, with or without anti-VEGF and, if RAS wild-type, with or without anti-EGFR, and
at least one approved subsequent line of therapy with trifluridine-tipiracil, regorafenib or fruquintinib, or where these agents are not suitable due to contraindication or prior intolerance;
Patients with primary brain tumors, brain metastases or CNS disease will be excluded.
Chemotherapy, immunotherapy, or radiation therapy at the tumor sites within 4 weeks prior to study treatment start.
Active or history of autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
Previous or concurrent cancer type that is distinct from the cancer being evaluated in this study. Exception made for any other cancer curatively treated ≥ 2 years prior to study treatment start.
Philogen S.p.A.
Lead sponsor