NCT05678257

A Study of NUC-3373 in Combination With Other Agents in Patients With Colorectal Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: NuCana plc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, dose/schedule optimization study comparing NUC-3373/leucovorin (LV)/irinotecan plus bevacizumab (NUFIRI-bev) to 5-FU/LV/irinotecan plus bevacizumab (FOLFIRI-bev) for the treatment of patients with unresectable metastatic colorectal cancer. A total of 171 patients will be randomized 1:1:1 to either NUFIRI-bev on a weekly NUC-3373 schedule, NUFIRI-bev based on an alternate weekly NUC-3373 schedule, or FOLFIRI bev on an alternate weekly schedule. The main objectives are to assess and compare the efficacy and safety of the 3 regimens. Pharmacokinetics will be assessed on the 2 NUFIRI arms.

Conditions

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Adenocarcinoma
• Colorectal Cancer Metastatic
• Neoplasm, Colorectal

Interventions

Type	Name	Description
DRUG	Fosifloxuridine Nafalbenamide	Intravenous infusion
DRUG	Leucovorin	Intravenous infusion
DRUG	Irinotecan	Intravenous infusion
BIOLOGICAL	Bevacizumab	Intravenous infusion
DRUG	5-FU	Intravenous infusion

Timeline

• Start date: 2023-04-18
• Primary completion: 2024-08-29
• Completion: 2024-08-29
• First posted: 2023-01-10
• Last updated: 2025-09-12
• Results posted: 2025-09-12

Locations

59 sites across 6 countries: United States, France, Germany, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study