A Phase 3 Study of Ersodetug in Patients With Tumor-Associated Hyperinsulinism

Launched by REZOLUTE · Mar 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ersodetug for people with Tumor-Associated Hyperinsulinism (tHI), a condition where the body makes too much insulin, leading to low blood sugar levels (hypoglycemia). The goal is to see how well ersodetug works in managing these low blood sugar episodes, as well as how safe and tolerable it is for patients. The trial is not yet recruiting participants, but when it does, it will include adults aged 18 and older who have a specific type of tumor causing their hypoglycemia and have not improved with other standard treatments.

To be eligible, participants must have experienced frequent low blood sugar events (at least three times a week) that do not respond to surgery or usual treatments. Those who have recently started or changed their cancer treatments or other medications for managing low blood sugar may not be able to participate. Throughout the study, participants will be closely monitored, and they can expect to receive either the study drug or a placebo (a non-active treatment) to compare the effects. This trial aims to help improve care for individuals struggling with this challenging condition.

Gender

ALL

Eligibility criteria

• • Double-Blind Arm: (Ambulatory ICT and Ambulatory NICT participants)
• Inclusion Criteria:
• • The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI which must include an oncologist
• • Male or female participants of ≥18 years of age who provide written informed consent
• • Participants with a clinical diagnosis and laboratory confirmation of ICT or NICT, with associated hypoglycemia that is considered refractory to surgery and to usual SOC anti-hypoglycemia therapies, per investigator judgement.
• • Experiencing an average of ≥ 3 hypoglycemia events per week that meet Level 2 criteria and/or Level 3 criteria during the two weeks before randomization
• Exclusion Criteria:
• • Participants who have not previously received tumor-directed therapy (including at least one course/trial of systemic tumor-directed therapy, as appropriate) but are considered appropriate for tumor-directed therapies by the investigator and/or a multi-disciplinary oncology care team.
• • Initiation of, or changes to tumor directed therapies within 8 weeks prior to initiation of study drug, or expected initiation or significant changes to these therapies over the course of the pivotal treatment period
• • Initiation of, or significant changes to, SOC medical (e.g. diazoxide, SSAs, continuous glucagon, mTOR-Inhibitors, etc.) or supplemental enteral treatments (e.g. continuous tube feeds) used for the chronic management of hypoglycemia within 4 weeks of screening (per investigator's discretion), or expected changes to SOC medical therapies over the course of the pivotal treatment period.
• • Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator.
• • Open-Label Arm: (Hospitalized ICT and NICT participants)
• Inclusion Criteria:
• • The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI which must include an oncologist
• • Male or female participants of ≥18 years of age who provide written informed consent.
• • Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tHI confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
• • Requiring IV glucose infusion and/or parenteral nutrition for ≥3 days for management of uncontrolled hypoglycemia
• Exclusion Criteria:
• • Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
• • Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator.
• • Any organ condition, concomitant disease (e.g., psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which in the opinion of the investigator and/or Sponsor's Medical Monitor would pose an unacceptable risk to the participant in the study.