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A Phase I/II, Open-label, Dose-escalation and Expansion Study to Assess the Safety, Pharmacokinetics and Clinical Activity of NUC-7738, a Nucleotide Analogue, in Patients With Advanced Solid Tumours and Lymphoma
Led by NuCana plc · Updated on 2026-01-12
135
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating NUC-7738, a nucleotide analogue, in patients with advanced solid tumours and lymphoma through a Phase I/II dose-escalation and expansion study. The study aims to assess the safety, tolerability, and appropriate dosing schedule of NUC-7738 given alone or combined with pembrolizumab. The trial includes patients with various advanced cancers, including cutaneous melanoma and lymphoma, to explore treatment effects and clinical activity of these therapies. Participants receive NUC-7738 intravenously on either a weekly or fortnightly schedule. In combination cohorts, pembrolizumab is administered intravenously every three weeks alongside NUC-7738. Phase I focuses on dose escalation and safety across two dosing schedules, while Phase II involves dose confirmation and expansion in additional patients, including specific cohorts for melanoma and lymphoma. Biopsies are required for most patients to monitor tumour response. During the study, participants undergo regular assessments including tumour size evaluation every 8 weeks, laboratory tests, physical exams, vital signs monitoring, and electrocardiograms up to 22 months. Researchers will track adverse events, dose-limiting toxicities, pharmacokinetics, and clinical responses such as objective response rate and disease control rate. The study continues safety monitoring until 30 days after the last dose, with detailed pharmacokinetic sampling during early cycles.
CONDITIONS
Brief Title
A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent is provided.
- Histologically confirmed advanced solid tumour with measurable or evaluable disease for solid tumour cohorts.
- For metastatic cutaneous melanoma cohort: confirmed diagnosis with measurable disease and progression on two or fewer prior therapies, including PD-1/PD-L1 treatment.
- For lymphoma cohort: relapsed or refractory lymphoma not suitable for standard care with measurable disease.
- No more than 3 prior lines of treatment for metastatic disease in single-agent solid tumour Phase II cohorts.
- Age 18 years or older, no upper age limit.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy of 12 weeks or more.
- Adequate bone marrow, liver, and kidney function.
- Ability to follow study requirements.
- Negative pregnancy test for females of child-bearing potential within 3 days before first dose; agreement to use effective contraception or abstinence from screening through 6 months after last dose.
- Willingness to undergo tumour biopsy at screening and during therapy unless clinically unsafe.
- Agreement to avoid or minimize UV light exposure during study and for 4 weeks after last dose.
You will not qualify if you...
- History of allergic reactions to any components of NUC-7738.
- Central nervous system or leptomeningeal metastases, except stable brain metastases without symptoms or recent corticosteroids.
- Recent chemotherapy, radiotherapy, immunotherapy, or investigational treatment within 28 days (with specific exceptions and washout periods).
- Unresolved toxicities from prior cancer treatments above grade 1, excluding certain neuropathy or alopecia.
- Uncontrolled or serious medical illnesses including severe heart conditions, recent heart attack, unstable angina, significant ECG abnormalities, risk factors for Torsades de Point.
- History or current interstitial lung disease or pulmonary fibrosis.
- Active infections including HIV, hepatitis B or C, or viral/bacterial infections like herpes zoster.
- Conditions affecting ability to consent or participate.
- Pregnancy, lactation, or breastfeeding.
- QTc interval above defined thresholds and use of drugs prolonging QT interval.
- Use of strong CYP3A4 inducers or inhibitors near study start.
- Live vaccination within 4 weeks before first dose.
- Additional exclusions for pembrolizumab combination cohort including hypersensitivity, contraindications to immunotherapy, current steroid or immunosuppressive therapy, autoimmune diseases, and prior cell therapy treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 22 months depending on treatment cycles and response
Participants receive NUC-7738 alone or in combination with pembrolizumab through intravenous infusions on a weekly or fortnightly schedule depending on the assigned cohort.
Weekly or fortnightly visits for NUC-7738 infusion depending on cohort; pembrolizumab administered every 3 weeks in combination cohort
Duration - 30 days
Participants are monitored for safety and clinical outcomes for 30 days after the last dose of NUC-7738.
Approximately 1 to 2 visits
Trial Site Locations
Total: 9 locations
1
Cambridge University Hospitals NHS Foundation Trust (Addenbrookes Hospital)
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
2
Edinburgh Cancer Centre, Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
3
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0TN
Actively Recruiting
4
University College London Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
5
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
6
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
7
Freeman Hospital
Newcastle, United Kingdom, NE7 7DN
Actively Recruiting
8
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
9
Lancashire Teaching Hospitals NHS Foundation Trust, Royal Preston Hospital
Preston, United Kingdom, PR2 9HT
Actively Recruiting
Research Team
N
NuTide:701 Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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