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NUC-3373 + leucovorin

Phase 1

Colorectal Cancer | Small molecule | Oncology |NuCana plc|Last Updated: Apr 23, 2025

Success Probability

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

NUC-3373 + leucovorin · 1 trial · 5 indications

Phase 1 1
NCT03428958A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer TreatmentColorectal Cancer
COMPLETED111 Analytics
PHASE1COMPLETED
A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage Change From Baseline in Tumour Size
Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)

Efficacy (per RECIST v 1.1): defined as the best percentage change from baseline in tumour size (mm)

Disease Control Rate (DCR)
Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)

Efficacy (per RECIST v 1.1): defined as the proportion of patients achieving confirmed response (CR and PR) or stable disease (SD) as the best overall response

Duration of Stable Disease (DoSD)
Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)

Efficacy (per RECIST v 1.1): defined as the time from the time measurement criteria are first met for SD until the first date that recurrence or progressive disease (PD) is objectively documented

Progression Free Survival (PFS)
Assessed every 8 weeks following Day 1 until the end of study (up to 25 months)

Efficacy (per RECIST v 1.1): defined as the time from first dose of study treatment until the date of objective disease progression or death

Overall Survival (OS)
From the date of randomization until the date of death from any cause, until the end of study (up to 25 months)]

Efficacy: defined as the time from randomization until the date of death from any cause

Best Overall Response
Assessed every 8 weeks from Day 1 until the end of study (up to 25 months)

Best overall response to study treatment according to RECIST v1.1

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NUC-3373 + leucovorin (LV) every other weekEXPERIMENTALArm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
NUC-3373 every other weekEXPERIMENTALArm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
NUC-3373 + leucovorin (LV) weeklyEXPERIMENTALArm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + leucovorin (LV); combination chemotherapy ineligibleEXPERIMENTALArm 1d: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV on Days 1, 8, 15 and 22 of 28-day cycles.
NUC-3373 + oxaliplatin weeklyEXPERIMENTALArm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUC-3373 + irinotecan weeklyEXPERIMENTALArm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUC-3373 + oxaliplatin (NUFOX) expansionEXPERIMENTALArm 2c: At the completion of Arm 2a, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
NUC-3373 + irinotecan (NUFIRI) expansionEXPERIMENTALArm 2d: At the completion of Arm 2b, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
NUFOX + bevacizumab weeklyEXPERIMENTALArm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
NUFOX + bevacizumab every other weekEXPERIMENTALArm 3b: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV+oxaliplatin+bevacizumab will be administered every other week.
NUFIRI + bevacizumab weeklyEXPERIMENTALArm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
NUFIRI + bevacizumab every other weekEXPERIMENTALArm 3d: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV+irinotecan+bevacizumab will be administered every other week.
NUC-3373 + LV + bevacizumab; maintenance patientsEXPERIMENTALArm 3e: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with bevacizumab (administered every other week).
NUFOX + cetuximabEXPERIMENTALArm 3f: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, oxaliplatin will be administered every other week and cetuximab will be administered weekly.
NUFIRI + cetuximabEXPERIMENTALArm 3g: NUC-3373, LV and irinotecan at dose levels used in Arm 2b may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, irinotecan will be administered every other week and cetuximab will be administered weekly.

Interventions

NameTypeDescription
NUC-3373 + leucovorinDRUGNUC-3373 + leucovorin
NUC-3373DRUGNUC-3373
NUFOXDRUGNUC-3373 + oxaliplatin
NUFOX + VEGF pathway inhibitorDRUGNUC-3373 + oxaliplatin + bevacizumab
NUFOX + EGFR inhibitorDRUGNUC-3373 + oxaliplatin + cetuximab/panitumumab
NUFIRIDRUGNUC-3373 + irinotecan
NUFIRI + VEGF pathway inhibitorDRUGNUC-3373 + irinotecan + bevacizumab
NUFIRI + EGFR inhibitorDRUGNUC-3373 + irinotecan + cetuximab/panitumumab
NUC-3373 + bevacizumabDRUGNUC-3373 + bevacizumab
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: All patients 1. Provision of written informed consent 2. Have histological confirmation of CRC with evidence of locally advanced/unresectable or metastatic disease 3. Age ≥18 years 4. Life expectancy of ≥12 weeks 5. ECOG Performance status 0 or 1 6. Measurable disease as define...

Countries:United StatesFranceUnited Kingdom
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Frequently asked questions about NUC-3373 + leucovorin

What is NUC-3373 + leucovorin used for?

NUC-3373 + leucovorin is an investigational small molecule combination being studied for the treatment of colorectal cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The combination is being evaluated for safety, pharmacokinetics, and efficacy in patients with colorectal cancer.

Who makes NUC-3373 + leucovorin?

NUC-3373 + leucovorin is being developed by NuCana plc, a biopharmaceutical company listed on the stock exchange under the ticker NCNA. The company is conducting clinical trials to evaluate this combination therapy for colorectal cancer.

What phase is NUC-3373 + leucovorin in?

NUC-3373 + leucovorin is in Phase 1 clinical development. It is an investigational drug combination and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the combination remains under investigation for colorectal cancer.

What clinical trials is NUC-3373 + leucovorin in?

NUC-3373 + leucovorin has been studied in one completed Phase 1 clinical trial, identified as NCT03428958. This trial was a safety, pharmacokinetic, and efficacy study of NUC-3373 in combination with standard agents used in colorectal cancer treatment, enrolling 111 participants across the United States, France, and the United Kingdom.

Is NUC-3373 + leucovorin the same as NUC-3373?

NUC-3373 + leucovorin is a combination regimen that includes NUC-3373 and leucovorin. NUC-3373 is the investigational drug being studied, and leucovorin is a standard agent used in colorectal cancer treatment. The combination is being evaluated in clinical trials for colorectal cancer.