OncoMatch/Clinical Trials/NCT05178693
Lutathera and ASTX727 in Neuroendocrine Tumours
Is NCT05178693 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies ASTX727 for neuroendocrine tumors.
Treatment: ASTX727 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: MKI67 Ki67 < 55% (< 55%)
Ki67 < 55%
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: somatostatin analogue — first line
Progression or intolerance to first line therapy including somatostatin analogues
Cannot have received: Lutathera or ASTX727
Previous treatment with either study medication
Cannot have received: radiation therapy
Exception: palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease and stereotactic radiotherapy to the CNS allowed with 1-week washout
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05178693 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Lutathera or ASTX727, radiation therapy disqualifies patients from enrollment.
Does this trial require MKI67?
Yes, MKI67 Ki67 < 55% is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages