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NCT06881992PHASE3Recruiting

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Rezolute

Start Date

4/16/2025

Completion Date

9/1/2027

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Ersodetug

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Conditions

Tumor Hyperinsulinism (Tumor HI)

Locations

Investigative Site

Chicago, Illinois 60637

United States

Investigative Site

Bethesda, Maryland 20892

United States

Investigative Site

Boston, Massachusetts 02114

United States

Investigative Site

Rochester, Minnesota 55905

United States

Investigative Site

New York, New York 10021

United States

Investigative Site

Canton, Ohio 44718

United States

Investigative Site

Portland, Oregon 97239

United States

Investigative Site

Houston, Texas 77030

United States

Investigative Site

Clichy, Île-de-France Region 92110

France

Investigative Site

Rotterdam, South Holland 3015

Netherlands

Investigative Site

Basel, Canton Basel-Stadt CH-4001

Switzerland

Investigative Site

Saint Johns Wood, London NW3 2QG

United Kingdom

Investigative Site

Withington, Manchester M20 4BX

United Kingdom