A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

NCT ID: NCT05364944

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-18
• Study Completion Date: 2024-12-03

Brief Summary

This is an open-label, single treatment arm, multicenter study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of Debio 4126 in the treatment of participants with Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine tumors (GEP-NETs).

Conditions

Acromegaly; GEP-NET

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A: Participants With Acromegaly

Participants will receive Sandostatin Long-acting repeatable (LAR) or Somatuline Autogel (ATG) (or equivalent formulations of octreotide/lanreotide) in Run-in Period and further will receive Debio 4126 in this group.

Group Type: EXPERIMENTAL

Debio 4126

Intervention Type: DRUG

Intramuscular (IM) injection

Sandostatin LAR

Intervention Type: DRUG

Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration

Somatuline ATG

Intervention Type: DRUG

Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration

Cohort B: Participants With GEP-NET

Participants will receive Sandostatin LAR or Somatuline ATG (or equivalent formulations of octreotide/lanreotide) in Run-in Period and further will receive Debio 4126 in this group.

Group Type: EXPERIMENTAL

Debio 4126

Intervention Type: DRUG

Intramuscular (IM) injection

Sandostatin LAR

Intervention Type: DRUG

Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration

Somatuline ATG

Intervention Type: DRUG

Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration

Interventions

Debio 4126

Intramuscular (IM) injection

Intervention Type: DRUG

Sandostatin LAR

Sandostatin LAR will be administered as IM injection as pre-study treatment dose prior to Debio 4126 administration

Intervention Type: DRUG

Somatuline ATG

Somatulin ATG will be administered as deep subcutaneous (SC) injection as pre-study treatment dose prior to Debio 4126 administration

Intervention Type: DRUG

Other Intervention Names

Octreotide acetate; Lanreotide acetate

Eligibility Criteria

Inclusion Criteria

For Participants with Acromegaly:

• Treatment with octreotide LAR (≤30 mg dose once in 4 weeks [Q4W] IM) or lanreotide ATG (≤120 mg Q4W or 120 mg once in 6 weeks [Q6W] to once in 8 weeks [Q8W] as deep SC injection) for at least 6 months overall, and for at least 2 months at a stable dose as monotherapy for acromegaly treatment prior to entering Run-in (Day -28). Octreotide doses of 10, 20, and 30 mg are considered similar to lanreotide doses of 60, 90, and 120 mg. Thus, a switch between similar doses of the two products will be considered as the patient remaining on a stable dose, unless due to efficacy or safety
• Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly will be carried out
• IGF-1 ≤1.3 x upper limit of normal (ULN) assessed centrally at screening

For Participants with GEP-NETs:

• Treatment with octreotide LAR (≤ 30 mg dose Q4W IM) or lanreotide ATG (≤ 120 mg Q4W or 120 mg Q6W to Q8W as deep SC injection) for at least 6 months overall, and for at least 2 months at a stable dose as monotherapy for study disease treatment prior to entering Run-in (Day -28). Octreotide doses of 10, 20, and 30 mg are considered similar to lanreotide doses of 60, 90, and 120 mg. Thus, a switch between similar doses of the two products will be considered as the participant remaining on a stable dose, unless due to efficacy or safety
• Participants with functioning, well-differentiated (Grade 1 or Grade 2) GEP-NET with symptoms of carcinoid syndrome which are controlled by Sandostatin LAR, Somatuline ATG, or equivalent medications; sporadic use of rescue medication for symptom control, e.g., bowel movements and/or flushing, is allowed

Exclusion Criteria

For Participants with Acromegaly and GEP-NETs:

• Known ongoing gallbladder or bile duct disease or acute or chronic pancreatitis
• Hypothyroidism not adequately treated with thyroid hormone replacement therapy
• Diabetic participants whose blood glucose is poorly controlled despite adequate therapy, as evidenced by glycated hemoglobin (HbA1c) >8.0% at screening
• Cardiology:

1. Known left ventricular ejection fraction <50%, left ventricular hypertrophy, ventricular arrhythmias, bradycardia (heart rate <50 beats per minute [bpm]), cardiomyopathy

2. New York Heart Association Class ≥3 heart failure

3. Congenital long QT syndrome or

4. Known family history of long QT syndrome or sudden cardiac death before the age of 50

5. Symptomatic Pulmonary embolism

6. QT interval corrected for heart rate according to Fridericia's formula (QTcF) at screening >450 milliseconds (msec) for males and >470 msec for females, based on the average of a triplicate ECG

For Participants with Acromegaly:

• Participants who received pituitary irradiation <2 years prior to enrollment as stereotactic radiotherapy or <3 years prior to enrollment for conventional radiotherapy
• Participants who received medical treatment with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening)
• Participants who have undergone pituitary surgery within 6 months prior to screening

For Participants with GEP-NETs:

• Participants with short-bowel syndrome
• Participants with poorly differentiated neuroendocrine carcinoma and/or high-grade neuroendocrine carcinoma
• Participants who have received any previous therapy with interferons, targeted therapies (e.g., everolimus, sunitinib, bevacizumab), chemotherapy or other anti-neoplastic systemic therapies administered for more than 1 month and within 12 weeks prior to the start of the Run-in period
• Participants having history of hepatic embolization, hepatic arterial chemoembolization, and/or selective internal radiation (SIR) therapy within less than 6 months prior to screening
• Participants who have received Peptide receptor radionuclide therapy (PRRT) therapy during the last 12 months prior to screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Debiopharm International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rigshospitalet, Endokrinologisk afdeling

Copenhagen, , Denmark

CHU Angers

Angers, , France

AP-HP Hopital Bicetre

Le Kremlin-Bicêtre, , France

AP-HM - Hôpital de la Conception, Service d'Endocrinologie et Centre de Référence des Maladies Rares de l'hypophyse

Marseille, , France

Medicover Praxis fur Neuroendokrinologie

Munich, , Germany

Rabin Medical Center, Beilinson Hospital, Clalit Health Services by Rabin Medical Center, Beilinson Hospita

Petah Tikva, , Israel

Sheba Medical Center, Endocrine institute

Ramat Gan, , Israel

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, , Italy

Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, , Poland

Mazowiecki Szpital Brodnowski - Zespol Oddzialow Chorob Wewnetrznych, Endokrynologii i Diabetologii

Warsaw, , Poland

Hospital de la Santa Creu i Sant Pau Barcelon

Barcelona, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

University Hospital Coventry, WISDEM Centre, UHCW NHS Trust

Coventry, , United Kingdom

Royal Free London NHS Foundation Trust

London, , United Kingdom

Countries

Denmark; France; Germany; Israel; Italy; Poland; Spain; United Kingdom

Other Identifiers

2021-005035-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Debio 4126-102

Identifier Type: -

Identifier Source: org_study_id