Lutathera and ASTX727 in Neuroendocrine Tumours

NCT05178693 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-11-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ASTX727

Cedazuridine 100mg + 35mg decitabine

RADIATION

Lutathera

Peptide receptor radionuclide therapy (PRRT)

Sponsors & Collaborators

  • Advanced Accelerator Applications

    collaborator INDUSTRY
  • Imperial College London

    lead OTHER

Principal Investigators

  • Rohini Sharma, Professor · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2026-06-30
Completion
2029-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05178693 on ClinicalTrials.gov