Phase Ib study of DEB 4126 in Acromegaly and GEP-NET patients
Research type
Research Study
Full title
A Phase 1b study in patients with acromegaly or functioning gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to characterize the pharmacokinetics, pharmacodynamics, safety and tolerability of Debio 4126, a 12-week prolonged-release octreotide formulation
IRAS ID
308677
Contact name
Minal Kara
Contact email
Sponsor organisation
Debiopharm International S.A.
Eudract number
2021-005035-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 6 days
Research summary
DEB-4126 is a phase 1b, open-label, two parallel-cohort, single treatment arm, multicentre study, evaluating new study medication, Debio 4126 and its efficacy and safety in users. The main ingredient of Debio 4126 is octreotide, which is available on the market as an immediate release formula and a 4-week long-acting formula. This new formulation, Debio 4126, is a 12-week long-acting formula, which benefits users by reducing the frequency of treatment injections.
The primary objective is to determine the length of time Debio 4126 remains effective in the blood by comparing the blood level of Debio 4126 to a threshold value over several visits throughout the 12-week dosing interval.
Two participant cohorts will be enrolled simultaneously; those with acromegaly, where the body makes too much growth hormone and Insulin-like Growth factor 1, both of which help to promote normal bone and tissue growth and development; and those with gastroenteropancreatic neuroendocrine tumours (GEP-NETs), rare tumours of neuroendocrine origin. Selected participants will be ≥18 years of age, with the goal of recruiting 15 participants per group.
The dosage of Debio 4126 depends on dosage history of participants. Individuals who received 10 mg of the 4-week long-acting formula, will receive 30 mg of Debio 4126, similarly, individuals who received 20 mg and 30 mg of the 4-week long-acting formula, will receive 60 mg and 90 mg of Debio 4126, respectively.
This study will run for approximately 61 weeks consisting of a 4-week screening period, where participants are selected and a 4-week run-in period, where participants are monitored after receiving their normal dose of the 4-week long-acting formula. Followed by a 48-week treatment period, where participants will receive 4 doses of Debio 4126, 24 visits to the site will occur during this time. The study will end with a follow-up period of approximately 5 weeks.
Lay Summary of Results
Debio 4126 released octreotide into the blood over the full 12-week period. Higher doses of Debio 4126 led to higher levels of octreotide in the blood. The medicine did not build up in the body over time when four doses were given, one every 12 weeks. In most participants, the treatment helped keep hormone levels stable. 14 people started treatment in stable condition and had results available at both the start and end of treatment. In 13 out of these 14, levels of IGF 1 stayed within the target range (no more than 30% above the highest level considered normal). Debio 4126 was found to be safe and well tolerated. All three dose levels had similar safety results.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: This registry will not be updated to include a summary of results as this is an Adult Phase 1 study. The results will be posted on an alternative registry (EudraCT) however, which will not be publicly available as this is an Adult Phase I study.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 09/07/2025
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Participants have been informed that they may enquire into the results of the study directly with their study doctor.A Lay summary document of the study results has been prepared by the sponsor to assist them during conversations with participants.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Data will not be shared with others as this is an Adult Phase 1 study.
Have you enabled sharing of tissue samples and associated data with others?: Yes
If yes, describe or provide a URL: Consent was retrieved from participants regarding the use of their tissue samples and associated data for future research.
If no, explain why:
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London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0127
Date of REC Opinion
13 Apr 2022
REC opinion
Further Information Favourable Opinion