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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Lanreotide; Octreotide

Criteria

Main Inclusion Criteria:

For Participants with Acromegaly:

• Treatment with a stable dose of octreotide LAR (≤30 mg dose once in 4 weeks [Q4W] IM) or lanreotide ATG (≤120 mg Q4W as deep SC injection) for at least 2 months as monotherapy for acromegaly treatment prior to entering Run-in (Day -28)

• 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 a stable dose of octreotide LAR (≤ 30 mg dose Q4W IM) or lanreotide ATG (≤ 120 mg Q4W as deep SC injection) for at least 2 months prior to entering Run-in (Day -28)

• 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

Main 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. Left ventricular ejection fraction, left ventricular hypertrophy, ventricular arrhythmias, bradycardia, cardiomyopathy

2. Heart failure

3. Congenital long QT syndrome or

4. Known family history of long QT syndrome or sudden cardiac death

5. 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

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), or other investigational agents (within 30 days or 5 half-lives prior to screening, whichever is longer)

• 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

[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.]