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

NCT05678257 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-09-12

Study results available
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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

DRUG

Fosifloxuridine Nafalbenamide

Intravenous infusion

DRUG

Leucovorin

Intravenous infusion

DRUG

Irinotecan

Intravenous infusion

BIOLOGICAL

Bevacizumab

Intravenous infusion

DRUG

5-FU

Intravenous infusion

Sponsors & Collaborators

  • NuCana plc

    lead OTHER

Principal Investigators

  • Elisabeth Oelmann, MD, PhD · NuCana plc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-18
Primary Completion
2024-08-29
Completion
2024-08-29
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05678257 on ClinicalTrials.gov