Advanced CancerPhase 1/2NCT05714553
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
A Phase 1/2 study testing Fosifloxuridine Nafalbenamide, Leucovorin and Pembrolizumab in people with Advanced Cancer and Advanced Solid Tumor, run by NuCana plc at 4 sites in United Kingdom.
Trial summary
This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with different tumour types. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Advanced Solid Tumor, Neoplasm Malignant
- What is being tested?
- Fosifloxuridine Nafalbenamide, Leucovorin and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 8 Mar 2023to 30 May 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent.
- Confirmed diagnosis of one of the protocol-specified tumour types (refer to the relevant module for specific criteria).
- Age ≥18 years.
- Minimum life expectancy of ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.
- Measurable disease as defined by RECIST v1.1.
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- Adequate bone marrow function as defined by absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥100×109/L (with no evidence of bleeding), and haemoglobin ≥9 g/dL.
- Adequate liver function (refer to the relevant module for specific criteria).
- Adequate renal function assessed as serum creatinine <1.5× upper limit of normal (ULN) and glomerular filtration rate ≥50 mL/min (calculated by the Cockcroft-Gault method).
- Serum albumin ≥3 g/dL.
- For the module in which the patient will participate, there are no contra-indications to receiving the approved partner combination drugs.
- Ability to comply with protocol requirements.
- Female patients of child-bearing potential must have a negative pregnancy test within 7 days prior to the first study drug administration. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy. Male patients and female patients of child-bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception.
- Patients must have been advised to take measures to avoid or minimize exposure to ultraviolet (UV) light for the duration of study participation and for a period of 4 weeks following the last dose of study medication.
- Additional Module 1 Inclusion Criteria:
- Confirmed diagnosis of a solid tumour, with evidence of locally advanced/unresectable or metastatic disease, for which pembrolizumab treatment would be appropriate (e.g., melanoma, classical Hodgkin lymphoma, NSCLC, renal cell carcinoma (RCC), urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), cutaneous squamous cell carcinoma (cSCC), oesophageal carcinoma, microsatellite instability (MSI) high colorectal (CRC), gastric cancer, triple negative breast cancer (TNBC), and endometrial carcinoma).
- Must have progressed on ≤2 prior lines of therapy for advanced/metastatic disease, that may have included 1 prior line of an immunotherapy-containing regimen (either monotherapy or in combination with chemotherapy). Patients who have not progressed but where addition of NUC-3373 + LV to standard pembrolizumab monotherapy may be appropriate are also eligible (e.g., patients who could not tolerate post-IO standard of care therapy).
- Patient must be willing to undergo a new tumour biopsy at Screening and during therapy on the study. Biopsies are mandatory for patient inclusion, except where taking a biopsy would be associated with unacceptable clinical risk due to the location of the disease. A prior (archival) biopsy that is less than 6 months old (from the date of Cycle 1Day 1; C1D1) may be substituted for a fresh tumour biopsy at Screening.
- Adequate liver function, as defined by serum total bilirubin ≤1.5×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (or ≤5×ULN if liver metastases are present).
- Additional Module 2 Inclusion Criteria:
- Confirmed diagnosis of NSCLC (any histology) or pleural mesothelioma (any histology) with evidence of locally advanced/unresectable or metastatic disease.
- Must have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing standard of care regimens for advanced/metastatic disease (not including neoadjuvant or adjuvant therapy). Additional prior lines of treatment with targeted agents or immunotherapy are allowed as long as they were not given in combination with cytotoxic chemotherapy. Prior regimens in which one drug is substituted for another due to toxicity count as 1 line of treatment. Prior treatment with docetaxel for metastatic disease is not allowed.
- Adequate liver function, as defined by serum total bilirubin <ULN, AST and ALT ≤2.5×ULN (or ≤5×ULN if liver metastases are present). In the event of concomitantly increased alkaline phosphatase (ALP) values >2.5×ULN, AST and ALT must be <1.5×ULN.
Who cannot join
- History of hypersensitivity or current contra-indications to 5-fluorouracil (5-FU), floxuridine (FUDR), capecitabine (refer to latest package inserts), or the components of the NUC-3373 drug product formulation (super refined polysorbate 80 [SRP80], dimethylacetamide [DMA]).
- Symptomatic central nervous system or leptomeningeal metastases.
- Symptomatic ascites, ascites currently requiring drainage procedures or ascites requiring drainage over the 3 months prior to date of first dose of study drug.
- Chemotherapy, hormonal therapy, radiotherapy (other than a short cycle of palliative radiotherapy, e.g., for bone pain*), immunotherapy, biological agents, or exposure to another investigational agent within 21 days (or four times the half-life for molecular targeted agents, whichever is shorter) of first administration of study treatment:
- For nitrosoureas and mitomycin C within 6 weeks of first administration of NUC-3373
- Corticosteroid treatment is allowed during screening but should be weaned to a dose of 10 mg prednisolone (or steroid equivalent) by Cycle 1 Day 1 * Palliative radiotherapy during participation in the study is permitted, but should not be concurrent with study treatment and recovery should be allowed to prevent overlapping toxicity. It should not include a target lesion.
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- Residual toxicities from prior chemotherapy, immunotherapy or radiotherapy which have not regressed to Grade ≤1 severity (Common Terminology Criteria for Adverse Events (CTCAE) v5.0), except for alopecia, peripheral neuropathy and ototoxicity (which are excluded if ≥Grade 3).
- Uncontrolled concurrent cancer other than the indication under investigation. Patients with a concurrent cancer whose natural history or treatment does not have the potential to interfere with safety or efficacy assessment are eligible.
- Presence of an active bacterial or viral infection (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2), Herpes Zoster or chicken pox), or known active hepatitis B or C.
- Presence of any uncontrolled concurrent serious illness, medical condition or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's ability to participate in the study or with the interpretation of the results, including any of the following:
- Congestive heart failure (New York Heart Association Class III or Class IV)
- Clinically significant coronary heart disease or myocardial infarction within 6 months of the first dose of study medication or high risk of uncontrolled arrythmia
- Unstable or poorly controlled angina pectoris
- Complete left bundle branch, bifascicular block or other clinically significant abnormal electrocardiogram (ECG) finding
- Corrected QT (QTc) interval >470 milliseconds
- History of or current risk factor for torsade de pointes (e.g., heart failure, hypokalaemia, or a family history of long QT syndrome)
- History of severe skin reactions
- History of severe ocular disorders
- Interstitial pneumonitis or pulmonary fibrosis
- Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc.) that, in the judgment of the Investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
- Currently pregnant, lactating or breastfeeding.
- Required concomitant use of drugs known to prolong QT/QTc interval.
- Required concomitant use of strong CYP3A4 inducers or strong CYP3A4 inhibitors. The use of strong CYP3A4 inducers within 2 weeks of first receipt of study drug or the use of strong CYP3A4 inhibitors within 1 week of first receipt of study drug is also excluded.
- Use of live attenuated vaccines against infectious diseases (e.g., measles mumps rubella [MMR combined vaccines], Rotavirus, Chickenpox, yellow fever) within 4 weeks of initiation of study treatment.
- Known dihydropyrimidine dehydrogenase (DPD) or thymidine phosphorylase (TYMP) mutations associated with toxicity to fluoropyrimidines.
- Full-dose anti-coagulation treatment is prohibited. Use of warfarin and other types of long-acting anti-coagulants (such as phenprocoumon and anti-Xa inhibitors with a half-life of >12 hours) is prohibited within 4 weeks of the first dose of study treatment. Patients requiring low dose anti-coagulant treatment should switch to low molecular weight heparin or anti-Xa inhibitors with a half-life of ≤12 hours.
- Additional Module 1 Exclusion Criteria:
- Prior history of hypersensitivity or current contra-indication to immunotherapy with checkpoint inhibitors.
- Any history of hypersensitivity or current contra-indication to the components of pembrolizumab (L-histidine, polysorbate 80, sucrose, sodium hydroxide, hydrochloric acid).
- Any prior toxicity attributed to checkpoint inhibitors that resulted in discontinuation of therapy.
- Patients previously exposed to checkpoint inhibitors who are not adequately treated for skin rash or have no replacement therapy for endocrinopathies.
- Known neutralising antibodies against checkpoint inhibitors.
- Patients who have received >2 prior lines of therapy or who have received >1 prior line of an immunotherapy-containing regimen for advanced/metastatic disease.
- Systemic steroid therapy or any immunosuppressive therapy (≥10 mg/day prednisone or equivalent).
- Congenital or acquired immunodeficiency (e.g., serious active infection with human immunodeficiency virus (HIV)).
- Patients with a history of drug induced pneumonitis or current pneumonitis.
- Active autoimmune disease or a documented history of autoimmune disease, including ulcerative colitis and Crohn's disease or any condition that requires systemic steroids.
- Additional Module 2 Exclusion Criteria:
- Prior history of hypersensitivity or current contra-indication to docetaxel, polysorbate 80, ethanol (anhydrous) or citric acid.
- Total serum bilirubin >ULN and/or AST and ALT ≥1.5×ULN together with concomitantly increased ALP values >2.5×ULN.
- Patients who have received >2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease.
- Patients who have received prior treatment with docetaxel for advanced/metastatic disease.
- Congenital or acquired immunodeficiency (e.g., serious active infection with HIV). Patients with HIV who are healthy and have a low risk of acquired immunodeficiency syndrome (AIDS)-related outcomes are eligible.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Queen Elizabeth Hospital University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
The Beatson West of Scotland Cancer Centre
Glasgow, G12 0TN
Guy's and St Thomas NHS Foundation Trust
London, SE1 9RT
The Christie NHS Foundation Trust
Manchester, M20 4BX
About this study
Official title: A Phase Ib/II Open Label, Multi-arm, Parallel Cohort Dose Finding and Expansion Study to Assess the Safety, Pharmacokinetics and Efficacy of NUC-3373, a Nucleotide Analogue, Given in Combination With Standard Approved Agents in Patients With Advanced Solid Tumours
This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with different tumour types.
Each module is designed to evaluate a different NUC-3373 combination and consists of a dose-validation phase (Phase Ib) and a dose-expansion phase (Phase II).
Read more
Phase Ib of each module will determine the safety and tolerability of the combinations for further clinical evaluation in Phase II. Approximately 6-20 evaluable patients will be enrolled in the Phase Ib stage of each module to determine safety, tolerability, and preliminary efficacy of NUC-3373 in combination with other agents. Each module will then move into Phase II to enable a further assessment of safety and efficacy in approximately 20-40 patients.
Module 1 will assess NUC-3373 + leucovorin (LV) in combination with pembrolizumab for the treatment of patients with advanced/metastatic solid tumours who have progressed on ≤2 prior therapies for metastatic disease, that may have included 1 prior immunotherapy-containing regimen (either monotherapy or in combination with chemotherapy) or who have not progressed but where addition of NUC-3373 + LV to standard pembrolizumab monotherapy may be appropriate (e.g., patients who could not tolerate post- immuno-oncology (IO) standard of care therapy).
Module 2 will assess NUC-3373 + LV in combination with docetaxel for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease.
The opening of each module will be at the discretion of the Sponsor. Further modules may be added as non-clinical and clinical data become available to support additional NUC-3373 combinations and tumour types.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Neoplasm Malignant, Metastatic Cancer, Melanoma, Classical Hodgkin Lymphoma
- Being tested
- Fosifloxuridine Nafalbenamide, Leucovorin, Pembrolizumab, Docetaxel
- Keywords
- NuCana plc, NUC-3373, Fosifloxuridine nafalbenamide, Leucovorin, Pembrolizumab, Docetaxel, Antineoplastic agents, Chemotherapy, Locally advanced, Metastatic
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Melanoma, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Squamous Cell Carcinoma of Head and Neck, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosifloxuridine NafalbenamideDrug
Also called NUC-3373, Nucleotide analogue
Intravenous infusion
LeucovorinDrug
Also called Folinic acid, Levo-leucovorin
Intravenous infusion
PembrolizumabDrug
Also called Keytruda
Intravenous infusion
DocetaxelDrug
Also called Taxotere, Docecad, Docefrez
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Module 1 (NUC-3373 + LV + pembrolizumab) | Experimental | This Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase).
NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level. Receives: Drug: Fosifloxuridine Nafalbenamide; Drug: Leucovorin; Drug: Pembrolizumab |
| Module 2 (NUC-3373 + LV + docetaxel) | Experimental | This Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase).
NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level. Receives: Drug: Fosifloxuridine Nafalbenamide; Drug: Leucovorin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With DLTs in Each Module
The outcome measure presented is the number of DLTs per module
Measured: Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2
Secondary outcomes (2)
Number of Patients Achieving a Reduction in Tumour Volume (Objective Response Rate; ORR)
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 in Module 2 and by immune RECIST (iRECIST) criteria in Module 1:
CR= disappearance of all target lesions PR= at least a 30% decrease in the sum of the longest diameter of target lesions
Measured: Assessed from baseline to 30 days after last dose of study drug, up to 20 months
Number of Patients Achieving a Reduction or Stabilisation in Tumor Volume (Disease Control Rate; DCR)
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 in Module 2 and immune RECIST (iRECIST) criteria in Module 1:
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
Measured: Assessed from baseline to 30 days after the last dose of study drug, up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start8 Mar 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: The NuTide:303 study was terminated at NuCana's discretion following refinement of the NUC-3373 development strategy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuCana plc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714553
- Sponsor's protocol ID
- NuTide:303
- Other IDs
- 2022-000722-14
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2023
- Last updated
- 23 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Open Label, Multi-arm, Parallel Cohort Dose Finding and Expansion Study to Assess the Safety, Pharmacokinetics and Efficacy of NUC-3373, a Nucleotide Analogue, Given in Combination With Standard Approved Agents in Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT05714553
- Acronym / sponsor ID
- NuTide:303
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Neoplasm Malignant, Metastatic Cancer, Melanoma, Classical Hodgkin Lymphoma
- Keywords
- NuCana plc, NUC-3373, Fosifloxuridine nafalbenamide, Leucovorin, Pembrolizumab, Docetaxel, Antineoplastic agents, Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The NuTide:303 study was terminated at NuCana's discretion following refinement of the NUC-3373 development strategy.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NuCana plcUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Posted 23 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, multi-arm, parallel cohort, dose validation and expansion design. The study is modular in design, allowing evaluation of the safety, efficacy and pharmacokinetics (PK) of NUC-3373 in combination with other agents for the treatment of patients with different tumour types.
Each module is designed to evaluate a different NUC-3373 combination and consists of a dose-validation phase (Phase Ib) and a dose-expansion phase (Phase II).
Phase Ib of each module will determine the safety and tolerability of the combinations for further clinical evaluation in Phase II. Approximately 6-20 evaluable patients will be enrolled in the Phase Ib stage of each module to determine safety, tolerability, and preliminary efficacy of NUC-3373 in combination with other agents. Each module will then move into Phase II to enable a further assessment of safety and efficacy in approximately 20-40 patients.
Module 1 will assess NUC-3373 + leucovorin (LV) in combination with pembrolizumab for the treatment of patients with advanced/metastatic solid tumours who have progressed on ≤2 prior therapies for metastatic disease, that may have included 1 prior immunotherapy-containing regimen (either monotherapy or in combination with chemotherapy) or who have not progressed but where addition of NUC-3373 + LV to standard pembrolizumab monotherapy may be appropriate (e.g., patients who could not tolerate post- immuno-oncology (IO) standard of care therapy).
Module 2 will assess NUC-3373 + LV in combination with docetaxel for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease.
The opening of each module will be at the discretion of the Sponsor. Further modules may be added as non-clinical and clinical data become available to support additional NUC-3373 combinations and tumour types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module 1 (NUC-3373 + LV + pembrolizumab) | Experimental | Drug: Fosifloxuridine Nafalbenamide, Drug: Leucovorin, Drug: PembrolizumabThis Module is designed to evaluate the tolerability and the overall safety profile of NUC-3373 (1875 mg/m2) + LV (400 mg/m2) + pembrolizumab (200 mg) in the treatment of patients with advanced solid tumours (dose validation phase). NUC-3373 and LV will be administered on Days 1, 8 and 15 and pembrolizumab will be administered on Day 1 of 21-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level. |
| Module 2 (NUC-3373 + LV + docetaxel) | Experimental | Drug: Fosifloxuridine Nafalbenamide, Drug: Leucovorin, Drug: DocetaxelThis Module is designed to assess NUC-3373 (750 mg/m2) + LV (400 mg/m2) + docetaxel (55 mg/m2) for the treatment of patients with advanced/metastatic NSCLC or pleural mesothelioma who have progressed on, or were unable to tolerate, 1 or 2 prior lines of cytotoxic chemotherapy-containing regimens for advanced/metastatic disease (dose validation phase). NUC-3373 and LV will be administered on Days 1 and 22 and docetaxel will be administered on Day 8 of 28-day cycles. The dosing schedule may be adjusted based on emerging data with agreement from the Safety Review Committee. Following completion of the dose validation phase, expansion cohorts may be initiated at the selected dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Provision of written informed consent.
- Confirmed diagnosis of one of the protocol-specified tumour types (refer to the relevant module for specific criteria).
- Age ≥18 years.
- Minimum life expectancy of ≥12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1.
Key exclusion criteria (43 listed)
- History of hypersensitivity or current contra-indications to 5-fluorouracil (5-FU), floxuridine (FUDR), capecitabine (refer to latest package inserts), or the components of the NUC-3373 drug product formulation (super refined polysorbate 80 [SRP80], dimethylacetamide [DMA]).
- Symptomatic central nervous system or leptomeningeal metastases.
- Symptomatic ascites, ascites currently requiring drainage procedures or ascites requiring drainage over the 3 months prior to date of first dose of study drug.
- Chemotherapy, hormonal therapy, radiotherapy (other than a short cycle of palliative radiotherapy, e.g., for bone pain*), immunotherapy, biological agents, or exposure to another investigational agent within 21 days (or four times the half-life for molecular targeted agents, whichever is shorter) of first administration of study treatment:
- Residual toxicities from prior chemotherapy, immunotherapy or radiotherapy which have not regressed to Grade ≤1 severity (Common Terminology Criteria for Adverse Events (CTCAE) v5.0), except for alopecia, peripheral neuropathy and ototoxicity (which are excluded if ≥Grade 3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosifloxuridine NafalbenamideAlso: NUC-3373, Nucleotide analogueIntravenous infusion | Drug | Module 1 (NUC-3373 + LV + pembrolizumab), Module 2 (NUC-3373 + LV + docetaxel) |
| LeucovorinAlso: Folinic acid, Levo-leucovorinIntravenous infusion | Drug | Module 1 (NUC-3373 + LV + pembrolizumab), Module 2 (NUC-3373 + LV + docetaxel) |
| PembrolizumabAlso: KeytrudaIntravenous infusion | Drug | Module 1 (NUC-3373 + LV + pembrolizumab) |
| DocetaxelAlso: Taxotere, Docecad, DocefrezIntravenous infusion | Drug | Module 2 (NUC-3373 + LV + docetaxel) |
Primary outcome
Number of Participants With DLTs in Each Module
Time frame: Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2
The outcome measure presented is the number of DLTs per module
2 secondary outcomes
Number of Patients Achieving a Reduction in Tumour Volume (Objective Response Rate; ORR)
Time frame: Assessed from baseline to 30 days after last dose of study drug, up to 20 months
Number of Patients Achieving a Reduction or Stabilisation in Tumor Volume (Disease Control Rate; DCR)
Time frame: Assessed from baseline to 30 days after the last dose of study drug, up to 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fosifloxuridine Nafalbenamide, Leucovorin and Pembrolizumab in people with Advanced Cancer and Advanced Solid Tumor, run by NuCana plc at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With DLTs in Each Module (time frame: Assessed during Cycle 1 (first 28 days) in Module 1 and during Cycles 1 and 2 (first 56 days) in Module 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.