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A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

NCT ID: NCT06881992

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2027-09-30

Brief Summary

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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

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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).

Conditions

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Tumor Hyperinsulinism (Tumor HI)

Keywords

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Doege-Potter Syndrome Ectopic insulinoma Extra-pancreatic insulinoma Fibrosarcoma HCC Hyperinsulinemia Hypoglycemia Hypoglycemia due to fibrosarcoma Hypoglycemia due to HCC Hypoglycemia due to liposarcoma Hypoglycemia due to tumor/cancer IGF 2 Insulinoma IGF 2 mediated non islet cell tumor hypoglycemia IGF-2 mediated hypoglycemia IGF-2, Big IGF-2 IGF-oma, IGF-2-oma, Big IGF-2-oma Insulinoma Islet cell tumor (ICT) Liposarcoma Neuroendocrine tumor (NET) NICTH Non Islet Cell Tumor Non-islet cell tumor hypoglycemia (NICTH) Paraneoplastic Paraneoplastic hypoglycemia PNET Pro-insulinoma Tumor/cancer associated hypoglycemia Tumor/cancer induced hypoglycemia Tumor/cancer mediated hypoglycemia Clinical Trials for: -Insulinoma -proinsulinoma -extrapancreatic insulinoma -non-islet cell tumor -IGF-oma -HCC -Liposarcoma -Fibrosarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)

Group Type OTHER

Ersodetug

Intervention Type DRUG

Ersodetug (9 mg/kg) + SOC

Interventions

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Ersodetug

Ersodetug (9 mg/kg) + SOC

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rezolute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Investigative Site

Bethesda, Maryland, United States

Site Status NOT_YET_RECRUITING

Investigative Site

Boston, Massachusetts, United States

Site Status RECRUITING

Investigative Site

Rochester, Minnesota, United States

Site Status RECRUITING

Investigative Site

New York, New York, United States

Site Status NOT_YET_RECRUITING

Investigative Site

Canton, Ohio, United States

Site Status RECRUITING

Investigative Site

Portland, Oregon, United States

Site Status RECRUITING

Investigative Site

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Investigative Site

Clichy, Île-de-France Region, France

Site Status NOT_YET_RECRUITING

Investigative Site

Rotterdam, South Holland, Netherlands

Site Status NOT_YET_RECRUITING

Investigative Site

Basel, Canton Basel-Stadt, Switzerland

Site Status RECRUITING

Investigative Site

Saint Johns Wood, London, United Kingdom

Site Status NOT_YET_RECRUITING

Investigative Site

Withington, Manchester, United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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United States France Netherlands Switzerland United Kingdom

Central Contacts

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Rezolute Clinical Trial

Role: CONTACT

Phone: 650-206-4507

Email: [email protected]

Other Identifiers

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RZ358-302

Identifier Type: -

Identifier Source: org_study_id