Neoplasms

All Conditions

Musculoskeletal Diseases

Nervous System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Acromegaly

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Bone Diseases

Bone Diseases, Endocrine

Pituitary Diseases

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Octreotide

Lanreotide

Antineoplastic Agents, Hormonal

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.

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.

Debio 4126

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

Sandostatin LAR

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

Somatuline ATG

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).

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

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

The PK of Debio 4126 will be evaluated in plasma.

Pain VAS scale score will be assessed on 4-point rating scale, where 0=absent and 3=severe.

The blood samples will be collected to assess changes in the levels of IGF-1 (in µg/L) and GH (in µg/L).

Debiopharm International SA

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)	NCT05364944	Acromegaly GEP-NET	Debio 4126 Sandostatin LAR Somatuline ATG	18 Years -	Debiopharm International SA
A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)	NCT05364944	Acromegaly GEP-NET	Debio 4126 Sandostatin LAR Somatuline ATG	18 Years -	Debiopharm International SA

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