Actively Recruiting
Lutathera and ASTX727 in Neuroendocrine Tumours
Led by Imperial College London · Updated on 2025-11-24
27
Participants Needed
1
Research Sites
357 weeks
Total Duration
On this page
Sponsors
I
Imperial College London
Lead Sponsor
A
Advanced Accelerator Applications
Collaborating Sponsor
AI-Summary
What this Trial Is About
Patients entered into the study will receive ASTX727 orally for 5 days, prior to receiving Lutathera treatment on Day 8, to determine whether pre-treatment with ASTX727 results in re-expression of somatostatin receptor-2 in patients with metastatic neuroendocrine tumours. The study will use \[68Ga\]-DOTA-TATE PET to image epigenetic modification of the receptor locus.
CONDITIONS
Official Title
Lutathera and ASTX727 in Neuroendocrine Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Aged 18 years or older at consent
- Histologically or cytologically confirmed neuroendocrine tumour
- Archival tissue block available or willing to have fresh biopsy if not available
- Disease accessible for biopsy by ultrasound guidance (for 5 patients)
- Ki67 less than 55%; only well differentiated grade 1-3 NETs included
- Progression or intolerance to first line therapy including somatostatin analogues
- ECOG Performance status between 0 and 2
- No tumour uptake or uptake less than background liver on [68Ga]-DOTA-TATE
- Measurable disease by RECIST 1.1; progression demonstrated in previously irradiated lesions
- Adequate organ function per protocol
- Women of childbearing potential willing to use effective contraception through 6 months after last IMP dose
- Sexually active males agreeing to use contraception through 6 months after last study therapy dose
You will not qualify if you...
- Previous treatment with study medication or known hypersensitivity to it
- Serious concurrent illness including active infection
- History of organ transplant
- Known history of HIV infection
- Known history of active tuberculosis
- Known active CNS metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Bleeding or thrombotic disorders or risk of severe haemorrhage
- Participation in another investigational study or device use within 4 weeks before first IMP dose
- Known additional malignancy requiring treatment except certain skin or cervical cancers
- Conditions or therapies that may confound trial results or affect participation as judged by PI
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant or breastfeeding or planning pregnancy/fatherhood during trial and 6 months after
- Received live vaccine within 30 days before first ASTX727 dose; inactivated vaccines allowed
- Radiotherapy within 2 weeks before study start, with specified recovery requirements
- Other significant comorbidities compromising study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hammersmith Hospital
London, London, City of, United Kingdom, W12 0HS
Actively Recruiting
Research Team
R
Rohini Sharma, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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