Clinical trial details

A Randomised, Open-label, Phase II, Dose/Schedule Optimisation Study of NUC-3373/Leucovorin/Irinotecan Plus Bevacizumab (NUFIRI-bev) Versus 5-FU/Leucovorin/Irinotecan Plus Bevacizumab (FOLFIRI-bev) for the Treatment of Patients With Previously Treated Unresectable Metastatic Colorectal Cancer

Identifier

Nutide-323

Sponsor

NuCana plc

Principal Investigator

ELENA ELEZ FERNANDEZ

Service

Oncology


Study details

Tumor type: COLORECTAL
Stage: Advanced
Main Investigational Agent : Cytotoxic
Phase: II
Randomization: Randomized

Molecular details

Biomarker: BRAF known-stat; RAS known-stat
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: Fosifloxuridine nafalbenamide (NUC-3373), a pyrimidine nucleotide analogue, is a Thymidylate synthase inhibitor Inclusion criteria: Known RAS and BRAF status. Patients with wild-type KRAS tumours must have received prior treatment with an EGFR inhibitor, unless this was not standard of care according to relevant region-specific treatment recommendations. Known UGT1A1 status, or patient consents to UGT1A1 status testing if unknown.

Drug details

Arm A: FOLFIRI-bev on a Q2W schedule
Arm B: NUFIRI-bev(Fosifloxuridine Nafalbenamide + Leucovorin + Irinotecan + Bevacizumab) on a Q1W NUC-3373 schedule
Arm C: NUFIRI-bev(Fosifloxuridine Nafalbenamide + Leucovorin + Irinotecan + Bevacizumab) on a Q2W NUC-3373 schedule

Links

Clinical Trials GOV (NCT identifier): NCT05678257
EU Clinical Trials Register (eudraCT Identifier): 2022-001459-17