Actively Recruiting
A Safety, Pharmacokinetic and Clinical Activity Study of NUC-7738 in Patients With Advanced Solid Tumours and Lymphoma
Led by NuCana plc · Updated on 2026-01-12
135
Participants Needed
9
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II, dose-escalation and expansion study of NUC-7738 administered by intravenous infusion as a monotherapy and in combination with pembrolizumab. In Phase I, NUC-7738 monotherapy is evaluated across two administration schedules (weekly or fortnightly) in a dose-escalation design in patients with advanced solid tumours. The main objectives are to assess the safety and tolerability of NUC-7738, in addition to establishing the Maximum Tolerated Dose (MTD) and dose administration schedule of NUC-7738 for further exploration in the Phase II part of the study. In Phase II, the selected dose and designated dosing schedule will be further evaluated in dose-confirmation expansion cohorts enrolling a total of approximately 40 additional patients with advanced solid tumours. Based on emerging data, approximately 6 patients with cutaneous melanoma will be enrolled to these expansion cohorts and will receive NUC-7738 monotherapy. A further cohort will assess NUC-7738 in combination with pembrolizumab in approximately 6-12 patients with cutaneous melanoma. Based on efficacy signals observed in the initial melanoma combination cohort, a further expansion cohort will be initiated to expand to a total of 40 patients to allow a powered analysis. In addition, 12 patients with lymphoma (with potential expansion to a total of 25 patients) may be enrolled to receive NUC-7738 monotherapy.
CONDITIONS
Official 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 tumor with measurable or evaluable disease for solid tumor cohorts (Phase I and II, excluding combination cohort).
- Metastatic cutaneous melanoma with measurable disease and progression on at least two prior therapies, including PD-1/PD-L1 regimen for combination cohort (Phase II).
- Relapsed refractory lymphoma not amenable or refractory to standard care with measurable disease for lymphoma cohort (Phase II).
- No more than three prior treatments for metastatic disease in single-agent Phase II solid tumor cohorts.
- Age 18 years or older with no upper age limit.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Adequate bone marrow, liver, and kidney function.
- Ability to follow study requirements.
- Female patients of childbearing potential must have a negative pregnancy test within 3 days before first NUC-7738 dose.
- Agreement to practice abstinence or use two contraception methods from screening until 6 months after last study dose.
- Willingness to undergo tumor biopsies at screening and during therapy unless clinically unsafe.
- Advised to avoid or minimize skin and eye exposure to UV light during study and for 4 weeks after last dose.
You will not qualify if you...
- History of allergic reactions to components of NUC-7738.
- Presence of central nervous system or leptomeningeal metastases, except stable brain metastases without symptoms or recent corticosteroids.
- Recent chemotherapy, radiotherapy (except short palliative), immunotherapy, or other investigational agents within specified washout periods.
- Unresolved toxicities from previous anti-cancer treatments above Grade 1 severity (with some exceptions).
- Uncontrolled or serious illnesses including severe heart failure, recent heart attack, unstable angina, significant ECG abnormalities, risk factors for Torsades de Point, interstitial lung disease or fibrosis.
- Known HIV positive or active hepatitis B or C infection, or active bacterial/viral infections.
- Conditions impairing ability to consent or participate.
- Pregnancy, lactation, or breastfeeding.
- QTc interval above specified thresholds.
- Use of drugs prolonging QT/QTc interval or strong CYP3A4 inducers/inhibitors within specified time frames.
- Live vaccination within 4 weeks before first study dose.
- For combination cohort: hypersensitivity to pembrolizumab components, contraindications to immunotherapy, systemic steroid or immunosuppressive therapy, known neutralizing antibodies to checkpoint inhibitors, unresolved toxicities from checkpoint inhibitors, active or history of autoimmune disease, or prior cell therapy treatments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here