NCT07262970

Intermediate-Size Cohort EAP for Ersodetug in Patients With Inadequately Controlled Hypoglycemia Related to a Tumor

Intermediate-Size Cohort EAP for Ersodetug in Patients With Refractory Hypoglycemia Due to Tumor-Associated Hyperinsulinism (Tumor HI) Who Are Unable to Participate in a Clinical Trial

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Rezolute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This expanded access program is intended to provide ersodetug, an investigational drug, to eligible participants who suffer from inadequately controlled hypoglycemia due to tumor-associated hyperinsulinism and are unable to participate in ersodetug clinical trial. Participation is open to participants who meet the eligibility criteria and for whom access to the investigational drug is deemed appropriate by the treating physician.

Conditions

• Tumor-associated Hyperinsulinism (Tumor HI)

Interventions

Type	Name	Description
DRUG	Ersodetug (9 mg/kg) + SOC	Open-Label Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)

Timeline

• First posted: 2025-12-04
• Last updated: 2025-12-04