A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)
Summary
The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).
Detailed description
This study will include participants who are suffering from low blood sugar related symptoms (hypoglycemia) due to over-production of hormones (e.g. insulin or similar substances) by certain non-removable tumors that cannot be treated satisfactorily with available treatment. Every study participant will receive ersodetug doses weekly for 8 weeks alongside their usual treatments for hypoglycemia at a dose of 9 mg/kg. The study is divided into 3 periods: Screening (up to 4 weeks), Treatment (8 weeks) and either End of Study Follow-up (approximately up to 20 weeks after the last dose) or optional Open Label Extension (OLE) phase (up to 3 years). This study is being conducted at approximately 10-15 study sites in approximately 5 countries. The study will enroll approximately 16 participants, all with a diagnosis of tumor HI (insulin- or IGF producing tumors).
Arms & interventions
- DrugErsodetug
Ersodetug (9 mg/kg) + SOC
Outcome measures
Primary
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Time frame: 8 weeks
Secondary
Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).
Time frame: 8 weeks
Change from baseline in average daily total IV glucose delivery (g)
Time frame: 8 weeks
Time to complete weaning off IV glucose administration after initiating ersodetug.
Time frame: 8 weeks
Eligibility criteria
Study locations (8)
Investigative Site
Chicago, Illinois, 60637
Investigative Site
Bethesda, Maryland, 20892
Investigative Site
Boston, Massachusetts, 02114
Investigative Site
Rochester, Minnesota, 55905
Investigative Site
New York, New York, 10021
Investigative Site
Canton, Ohio, 44718
Investigative Site
Portland, Oregon, 97239
Investigative Site
Houston, Texas, 77030