Lutathera and ASTX727 in Neuroendocrine Tumours

Sponsor
Imperial College London
Study ID
NCT05178693
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ASTX727 — DRUG
    Cedazuridine 100mg + 35mg decitabine
  • Lutathera — RADIATION
    Peptide receptor radionuclide therapy (PRRT)

Study Details

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.

Key Dates

First listed
Jan 5, 2022
Start date
Apr 25, 2022
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Feb 28, 2029

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment

Primary Outcome Measure

To determine whether pre-treatment with ASTX727 results in re-expression of SSTR2 in patients with metastatic NETs, using [68Ga]-DOTA-TATE to image epigenetic modification of the SSTR2 locus allowing subsequent treatment with Lutathera [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

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