A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism (Tumor HI)

May 15, 2026 updated by: Rezolute

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Île-de-France Region
      • Clichy, Île-de-France Region, France, 92110
        • Recruiting
        • Investigative Site
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015
        • Recruiting
        • Investigative Site
  • Switzerland
    • Canton Basel-Stadt
      • Basel, Canton Basel-Stadt, Switzerland, CH-4001
        • Recruiting
        • Investigative Site
  • United Kingdom
    • London
      • Saint Johns Wood, London, United Kingdom, NW3 2QG
        • Recruiting
        • Investigative Site
    • Manchester
      • Withington, Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Investigative Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Investigative Site
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Not yet recruiting
        • Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Investigative Site
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Investigative Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Investigative Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Investigative Site
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
  • Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).

Exclusion Criteria:

  • Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
  • Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed
  • Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.
  • Known allergy or sensitivity to ersodetug or any component of the drug.
  • 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.
  • Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is <8 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)
Drug: Ersodetug
Ersodetug (9 mg/kg) + SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).
Time Frame: 8 weeks
8 weeks
Change from baseline in average daily total IV glucose delivery (g)
Time Frame: 8 weeks
8 weeks
Time to complete weaning off IV glucose administration after initiating ersodetug.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rezolute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RZ358-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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