Can an epigenetic pill boost a cancer radiation treatment?
NCT ID NCT05178693
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether a drug called ASTX727 can help a radiation therapy called Lutathera work better for people with metastatic neuroendocrine tumors. The idea is that ASTX727 may turn back on a receptor on tumor cells that Lutathera needs to target. About 27 participants will take ASTX727 for five days before receiving Lutathera, and researchers will use special scans to see if the receptor reappears.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ASTX727 (cedazuridine and decitabine) and Lutathera (lutetium Lu 177 dotatate)
- What this could lead to
- If it works, this could make Lutathera more effective for more patients with neuroendocrine tumors by reactivating a key receptor.
- What could go wrong
- This is a very early Phase 1 trial with only 27 people, so it may not show clear benefit. The combination could also cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be aged 18 or over at the day of signing consent 3. Histologic or cytologic confirmed diagnosis of neuroendocrine tumour 4. Have archival tissue block available or willing to have fresh tissue biopsy if blocks not available 5. Have disease that can be readily biopsied by ultrasound guidance (n=5) 6. Ki67 \< 55% (only patients with well differentiated grade 1-3 NETs will be included in the study as patients with poorly differentiated grade 3 NETs have a prognosis of less than 6 months) 7. Progression or intolerance to first line therapy including somatostatin analogues 8. ECOG Performance status 0 - 2 9. No tumoural uptake on \[68Ga\]-DOTA-TATE or uptake less than background liver 10. Measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions 11. Adequate organ function as outlined in the protocol 12. Women of childbearing potential must be willing to use a highly effective method of contraception as outlined in the protocol for the course of the study through 6 months after the last dose of Investigational Medicinal Product (IMP). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subjects 13. Sexually active males must agree to use an adequate method of contraception as outlined in the protocol starting with the first dose of IMP through 6 months after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject Exclusion Criteria: 1. Previous treatment with either study medication and/or known hypersensitivity to the study medication 2. Serious concurrent medical illness, including serious active infection 3. History of organ transplant 4. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority. 5. Has a known history of active Bacillus Tuberculosis (TB). 6. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. 7. Bleeding or thrombotic disorders or subjects at risk for severe haemorrhage 8. Is currently participating and receiving therapy or has participated or is participating in a study of an IMP or used an investigational device within 4 weeks of the first dose of IMP. 9. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 10. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Principal Investigator (PI). 11. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 12. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through to 6 months after the last dose of IMP. 13. Has received a live vaccine within 30 days of first dose of ASTX727 administration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. 14. Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and stereotactic radiotherapy to the CNS 15. Other clinically significant co-morbidities that could compromise the subject's participating in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hammersmith Hospital
RECRUITINGLondon, London, City of, W12 0HS, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Swiss registry aims to map rare neuroendocrine tumors
- Can patients drop monthly injections after targeted radiotherapy for neuroendocrine tumors?
- Can a vast image library unlock better pancreatic diagnoses?
- Can a sharper PET tracer light up hidden neuroendocrine tumors?
- Can patient records reveal who will respond to neuroendocrine tumor treatments?
- Can a new drug formulation shrink Hard-to-Treat neuroendocrine tumors?