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

PHASE1TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

May 18, 2022

Primary Completion Date

October 29, 2024

Study Completion Date

December 3, 2024

Conditions
AcromegalyGEP-NET
Interventions
DRUG

Debio 4126

Intramuscular (IM) injection

DRUG

Sandostatin LAR

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

DRUG

Somatuline ATG

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

Trial Locations (14)

2200

Rigshospitalet, Endokrinologisk afdeling, Copenhagen

13385

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

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan

41013

Hospital Universitario Virgen del Rocio, Seville

49100

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

49933

CHU Angers, Angers

81667

Medicover Praxis fur Neuroendokrinologie, Munich

94270

AP-HP Hopital Bicetre, Le Kremlin-Bicêtre

5265601

Sheba Medical Center, Endocrine institute, Ramat Gan

40-514

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

03-242

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

08041

Hospital de la Santa Creu i Sant Pau Barcelon, Barcelona

CV2 2DX

University Hospital Coventry, WISDEM Centre, UHCW NHS Trust, Coventry

NW3 2QG

Royal Free London NHS Foundation Trust, London

Sponsors
All Listed Sponsors
lead

Debiopharm International SA

INDUSTRY