NCT05178693

Lutathera and ASTX727 in Neuroendocrine Tumours

The Epigenetic Modification of Somatostatin Receptor-2 to Improve Therapeutic Outcome With Lutathera in Patients With Metastatic Neuroendocrine Tumours.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with neuroendocrine tumours (NET) who are found to be eligible will receive up to 4 doses of Lutathera on this trial. All participants will receive ASTX727 orally (cedazuridine 100mg + 35mg decitabine) Days 0-5 prior to receiving Lutathera Day 8 +/- 2days. Each cycle will be repeated every 2 months for 4 cycles unless unacceptable toxicity, progression of disease or withdrawal of patients' consent. Restaging will occur after 2 cycles of Lutathera and at the end of treatment. Patients will be followed 3 monthly until disease progression, death or withdrawal of patients' consent.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	ASTX727	Cedazuridine 100mg + 35mg decitabine
RADIATION	Lutathera	Peptide receptor radionuclide therapy (PRRT)

Timeline

• Start date: 2022-04-25
• Primary completion: 2026-06-30
• Completion: 2029-02-28
• First posted: 2022-01-05
• Last updated: 2025-11-24

Locations

1 site across 1 country: United Kingdom