A Phase 2 interventional study of Fosifloxuridine Nafalbenamide and Leucovorin in Colorectal Cancer, Colorectal Neoplasms and Colorectal Adenocarcinoma, sponsored by NuCana plc. Terminated at 59 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by NuCana plc · Phase 2, Interventional, and Treatment
Among 2,338 studies in Colorectal Neoplasms with a site in United States — 421 open to participants now, 629 under way, 30 of them phase 3. Colorectal Neoplasms · United States.
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 554th largest by enrollment of the 1,931 interventional ones that give a count, is one of 139 that started in 2023, is one of 509 in phase 2, and was the 1,842nd registered.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
Browse Colorectal Neoplasms studies →421 of the 2,338 studies in Colorectal Neoplasms with a site in United States are open now. Recruiting first, the newest first:
National Cancer Institute (NCI) · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 18+
City of Hope Medical Center · Sites in United States
Ages 40–80 · Men only
University of Pennsylvania · Sites in United States
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 18–85 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,338 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 817 · Phase 2 790 · Phase 3 132 · Phase 4 19
First in 1981; this study’s year is marked. 139 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 180 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,562 that completed or were terminated, 548 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
885 of 2,338 have an industry lead sponsor. The 10 most frequent:
NuCana plc is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
NuCana plc has 2 studies filed under Colorectal Neoplasms — fewer than ten, so there is no comparison to draw.
227 of the studies in Colorectal Neoplasms with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05141721Phase 3Seattle Project CorporationA Study of a Patient-Specific Neoantigen Vaccine in Combination With Immune Checkpoint Blockade for Patients With Metastatic Colorectal Cancer | 2027-03 |
| NCT04428905Phase 3City of Hope Medical CenterSelf-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer | 2027-03-31 |
| NCT02997228Phase 3National Cancer Institute (NCI)Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study | 2027-06-01 |
| NCT01349881Phase 3SWOG Cancer Research NetworkS0820, Adenoma and Second Primary Prevention Trial | 2027-09-15 |
| NCT03796884Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityLinaclotide in Treating Patients With Stages 0-3 Colorectal Cancer | 2026-11 |
Among the 2,338 studies in Colorectal Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Fosifloxuridine Nafalbenamide · Drug: Leucovorin · Drug: Irinotecan · Biological: Bevacizumab
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.
Drug: Fosifloxuridine Nafalbenamide · Drug: Leucovorin · Drug: Irinotecan · Biological: Bevacizumab
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.
Drug: Leucovorin · Drug: Irinotecan · Biological: Bevacizumab · Drug: 5-FU
Intravenous infusion
Also known as: NUC-3373, Nucleotide analogue
Intravenous infusion
Also known as: Folinic acid, LV
Intravenous infusion
Also known as: Campto, Camptosar
Intravenous infusion
Also known as: Avastin, Zirabev
Intravenous infusion
Also known as: 5FU, 5-fluorouracil, Fluorouracil
Median Progress-free Survival (PFS)
PFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
Time frame: Assessed from baseline to 30 days after last dose of study drug, up to 16 months
Number of Patients Achieving a Reduction in Tumour Volume
Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
Time frame: Assessed from baseline to 30 days after last dose of study drug, up to 16 months
Number of Patients Achieving Disease Control
Disease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease
Time frame: Assessed from baseline to 30 days after last dose of study drug, up to 16 months
A total of 180 patients were randomized between April 2023 and August 2024
| Milestone | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W |
|---|---|---|---|
| Started | 57 | 65 | 58 |
| Completed | 35 | 34 | 32 |
| Not completed | 22 | 31 | 26 |
| Withdrew: Withdrawal by subject | 2 | 0 | 5 |
| Withdrew: Physician decision | 1 | 0 | 1 |
| Withdrew: Adverse event | 1 | 3 | 1 |
| Withdrew: Progressive disease | 11 | 18 | 7 |
| Withdrew: No longer clinically benefitting | 2 | 1 | 0 |
| Withdrew: Sponsor decision | 5 | 9 | 8 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Patient non-compliance | 0 | 0 | 3 |
PFS assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, defined as the time from randomisation to the first observation of objective tumour progression or death from any cause. Progression was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in non-target lesions, or the appearance of new lesions.
| Months | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W |
|---|---|---|---|
| Median Progress-free Survival (PFS) | 5.68 (0.03 to 11.17) | 5.52 (0.03 to 10.84) | 9.03 (0.03 to 15.01) |
Objective response rate, defined as the percentage of patients achieving a complete (CR) or partial response (PR) to treatment. Response was measured by MRI scan and assessed per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
| Participants | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W |
|---|---|---|---|
| Number of Patients Achieving a Reduction in Tumour Volume | 4 | 12 | 12 |
Disease control rate, defined as the number of patients achieving a response (CR or PR) or stable disease (SD) as their best overall response. Disease control was measured by MRI scan and assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria: CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions SD= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease
| Participants | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W |
|---|---|---|---|
| Number of Patients Achieving Disease Control | 35 | 42 | 46 |
Collected over Each patient was assessed for adverse events from the date of informed consent until 30 days after the last dose of study treatment, up to 16 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NUFIRI-bev Q1W | 18/56 (32.1%) | 11/56 (19.6%) | 55/56 (98.2%) |
| NUFIRI-bev Q2W | 14/64 (21.9%) | 13/64 (20.3%) | 62/64 (96.9%) |
| FOLFIRI-bev Q2W | 6/57 (10.5%) | 17/57 (29.8%) | 57/57 (100%) |
| Event | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W |
|---|---|---|---|
| AstheniaGeneral disorders | 0/56 | 0/64 | 3/57 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/56 | 0/64 | 3/57 |
| DiarrheaGastrointestinal disorders | 2/56 | 2/64 | 0/57 |
| Intestinal obstructionGastrointestinal disorders | 2/56 | 1/64 | 2/57 |
| HyperbilirubinemiaHepatobiliary disorders | 2/56 | 0/64 | 0/57 |
| NauseaGastrointestinal disorders | 0/56 | 2/64 | 0/57 |
| VomitingGastrointestinal disorders | 0/56 | 2/64 | 0/57 |
| HypotensionVascular disorders | 1/56 | 0/64 | 0/57 |
| PyrexiaGeneral disorders | 1/56 | 0/64 | 1/57 |
| Inadequate analgesiaGeneral disorders | 1/56 | 0/64 | 0/57 |
| Event | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 35/56 | 33/64 | 28/57 |
| NauseaGastrointestinal disorders | 29/56 | 37/64 | 22/57 |
| AstheniaGeneral disorders | 25/56 | 23/64 | 26/57 |
| VomitingGastrointestinal disorders | 22/56 | 18/64 | 9/57 |
| Abdominal painGastrointestinal disorders | 18/56 | 13/64 | 8/57 |
| NeutropeniaBlood and lymphatic system disorders | 4/56 | 4/64 | 16/57 |
| Decreased appetiteMetabolism and nutrition disorders | 13/56 | 11/64 | 16/57 |
| Alanine aminotransferase increasedInvestigations | 14/56 | 4/64 | 4/57 |
| AlopeciaSkin and subcutaneous tissue disorders | 3/56 | 0/64 | 14/57 |
| HeadacheNervous system disorders | 13/56 | 6/64 | 2/57 |
| Age, Continuous(Years) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| Median | 64.0 (38 to 78) | 64.0 (37 to 79) | 65.0 (27 to 85) | 64.0 (27 to 85) |
| Sex: Female, Male(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| Female | 21 | 27 | 24 | 72 |
| Male | 36 | 38 | 34 | 108 |
| Race (NIH/OMB)(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 2 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 4 | 11 |
| White | 42 | 44 | 42 | 128 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 9 | 16 | 12 | 37 |
| ECOG performance status(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| 0 | 31 | 36 | 38 | 105 |
| 1 | 25 | 28 | 18 | 71 |
| Not reported | 1 | 1 | 2 | 4 |
| Stage at initial diagnosis(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| Stage I (A-C) | 0 | 0 | 2 | 2 |
| Stage II (A-C) | 3 | 1 | 3 | 7 |
| Stage IIIA | 2 | 3 | 1 | 6 |
| Stage IIIB | 4 | 13 | 9 | 26 |
| Stage IIIC | 2 | 2 | 6 | 10 |
| Stage IV | 30 | 28 | 24 | 82 |
| Stage IVA | 11 | 8 | 9 | 28 |
| Stage IVB | 3 | 4 | 4 | 11 |
| Stage IVC | 1 | 3 | 0 | 4 |
| Not reported | 1 | 3 | 0 | 4 |
| Primary tumor location(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| Colon - right side | 15 | 26 | 15 | 56 |
| Colon - left side | 20 | 23 | 21 | 64 |
| Colon - unknown | 6 | 5 | 8 | 19 |
| Rectum | 16 | 11 | 14 | 41 |
| Liver metastases(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| Yes | 46 | 45 | 35 | 126 |
| No | 11 | 20 | 23 | 54 |
| Number of metastatic sites(Participants) | NUFIRI-bev Q1W | NUFIRI-bev Q2W | FOLFIRI-bev Q2W | Total |
|---|---|---|---|---|
| 1 | 1 | 2 | 3 | 6 |
| 2 | 9 | 10 | 7 | 26 |
| 3 | 19 | 16 | 20 | 55 |
| 4 or more | 28 | 36 | 28 | 92 |
| Not reported | 0 | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2023 to primary completion in Aug 2024, 16 months.
Results were first posted in Sep 2025, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Fosifloxuridine nafalbenamide
NuCana plc