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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fosifloxuridine Nafalbenamide — DRUG
  Intravenous infusion
• Leucovorin — DRUG
  Intravenous infusion
• Irinotecan — DRUG
  Intravenous infusion
• Bevacizumab — BIOLOGICAL
  Intravenous infusion
• 5-FU — DRUG
  Intravenous infusion

Study Details

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.

Key Dates

Start date

Apr 18, 2023

Status verified

Aug 2025

Primary completion

Aug 29, 2024

Completion

Aug 29, 2024

Study Design

Enrollment

180 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NUFIRI-bev on a Q1W NUC-3373 schedule
  Arm A: Study treatment will be administered in 28-day cycles as follows: 1. Bevacizumab 5 mg/kg on Days 1 and 15: * 90 minutes for the first dose * 60 minutes for the second dose (if first dose is tolerated) * 30 minutes for subsequent doses (if second dose is tolerated) 2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22. 3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15. 4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
• Experimental: NUFIRI-bev on a Q2W NUC-3373 schedule
  Arm B: Study treatment will be administered in 28-day cycles as follows: 1. Bevacizumab 5 mg/kg on Days 1 and 15: * 90 minutes for the first dose * 60 minutes for the second dose (if first dose is tolerated) * 30 minutes for subsequent doses (if second dose is tolerated) 2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15. 3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15. 4. NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15.
• Active Comparator: FOLFIRI-bev on a Q2W schedule
  Arm C: Study treatment will be administered in 28-day cycles as follows: 1. Bevacizumab 5 mg/kg on Days 1 and 15: * 90 minutes for the first dose * 60 minutes for the second dose (if first dose is tolerated) * 30 minutes for subsequent doses (if second dose is tolerated) 2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15. 3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15. 4. 5-FU 400 mg/m2 bolus on Days 1 and 15. 5. 5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.

Primary Outcome Measure

Median Progress-free Survival (PFS) [ Time Frame: Assessed from baseline to 30 days after last dose of study drug, up to 16 months ]

Locations (16)

Find similar trials in Newark, DE

Related Studies

• ColoCare Study - Colorectal Cancer Cohort
  Recruiting · University of Utah · Los Angeles, California
• Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
  PHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts
• A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
  PHASE1/PHASE2 · Recruiting · Merus B.V. · La Jolla, California
• Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies
  PHASE1/PHASE2 · Recruiting · Anwaar Saeed · Westwood, Kansas