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setidegrasib + liposomal irinotecan + fluorouracil + leucovorin + oxaliplatin
- Development stage
- Phase 3
- Lead developer
- Astellas Pharma
- Modality
- PROTACs (E3 ligase recruitment) → Targeted Protein Degraders (TPDs) → Small Molecules, Bivalent/Multivalent Binders → Multivalent & Scaffold-Based Small Molecules → Small Molecules, Nanoparticles → Drug Delivery Systems
- Administration
- Intravenous
01
Overview
Setidegrasib (ASP3082) in combination with liposomal irinotecan, fluorouracil, leucovorin, and oxaliplatin (NALIRIFOX) is an investigational combination regimen being evaluated for the treatment of KRAS G12D-mutated advanced solid tumors, particularly metastatic pancreatic ductal adenocarcinoma (PDAC). Setidegrasib is a first-in-class, selective, small-molecule proteolysis-targeting chimera (PROTAC) that induces the degradation of mutant KRAS G12D protein by recruiting the von Hippel-Lindau (VHL) E3 ubiquitin ligase. The chemotherapy backbone NALIRIFOX consists of liposomal irinotecan (a topoisomerase I inhibitor), fluorouracil (a thymidylate synthase inhibitor), leucovorin (a folate analog that enhances fluorouracil activity), and oxaliplatin (a platinum-based DNA alkylating agent). This combination is being evaluated in Phase III clinical trials as a first-line treatment to improve survival outcomes in patients with KRAS G12D-mutated metastatic pancreatic cancer.
- Other names
- ASP3082 + NALIRIFOXASP3082 + liposomal irinotecan + fluorouracil + leucovorin + oxaliplatinsetidegrasib + NALIRIFOXsetidegrasib + liposomal irinotecan + fluorouracil + leucovorin + oxaliplatin
02
Targets
DNATOP1 (DNA Topoisomerase I)KRAS (Kirsten rat sarcoma viral oncogene homolog)TS (Thymidylate synthase)VHL (Von Hippel–Lindau tumor suppressor protein)
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