RZ358-302
Research type
Research Study
Full title
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-Associated Hyperinsulinism (Tumor HI)
IRAS ID
1011898
Contact name
Melanie Pooler
Contact email
Sponsor organisation
Rezolute, Inc
Eudract number
2024-515447-36
Clinicaltrials.gov Identifier
Research summary
Objective: The objective of this study is to test the safety and effectiveness of the study drug for tumor HI when added to usual
treatments (also called standard of care or SOC). The study also includes an extended phase (open label extension [OLE]) in which participants may continue to receive the study drug for purposes of understanding longer term safety and effectiveness.
Trial design: 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-removeable 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 OLE phase (up to 3 years).
Participants should continue to use usual tumor HI medications commonly used to control hypoglycemia symptoms throughout the study. Prescribed anti-cancer medications may be adjusted by a participant’s doctor. During the study, it is possible that participants may not be allowed to take certain prescription medications
Trial population: 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).REC name
Wales REC 5
REC reference
25/WA/0191
Date of REC Opinion
11 Nov 2025
REC opinion
Further Information Favourable Opinion