NCT06881992

Brief 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).

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
16mo left

Started Apr 2025

Geographic Reach
5 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Apr 2025Sep 2027

First Submitted

Initial submission to the registry

March 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

April 16, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

March 10, 2025

Last Update Submit

April 15, 2026

Conditions

Tumor Hyperinsulinism (Tumor HI)

Keywords

Doege-Potter SyndromeEctopic insulinomaExtra-pancreatic insulinomaFibrosarcomaHCCHyperinsulinemiaHypoglycemiaHypoglycemia due to fibrosarcomaHypoglycemia due to HCCHypoglycemia due to liposarcomaHypoglycemia due to tumor/cancerIGF 2 InsulinomaIGF 2 mediated non islet cell tumor hypoglycemiaIGF-2 mediated hypoglycemiaIGF-2, Big IGF-2IGF-oma, IGF-2-oma, Big IGF-2-omaInsulinomaIslet cell tumor (ICT)LiposarcomaNeuroendocrine tumor (NET)NICTHNon Islet Cell TumorNon-islet cell tumor hypoglycemia (NICTH)ParaneoplasticParaneoplastic hypoglycemiaPNETPro-insulinomaTumor/cancer associated hypoglycemiaTumor/cancer induced hypoglycemiaTumor/cancer mediated hypoglycemiaClinical Trials for: -Insulinoma -proinsulinoma -extrapancreatic insulinoma -non-islet cell tumor -IGF-oma -HCC -Liposarcoma -Fibrosarcoma

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.

    8 weeks

Secondary Outcomes (3)

  • Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).

    8 weeks

  • Change from baseline in average daily total IV glucose delivery (g)

    8 weeks

  • Time to complete weaning off IV glucose administration after initiating ersodetug.

    8 weeks

Study Arms (1)

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

OTHER
Drug: Ersodetug

Interventions

ErsodetugDRUG

Ersodetug (9 mg/kg) + SOC

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Investigative Site

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Investigative Site

Bethesda, Maryland, 20892, United States

NOT YET RECRUITING

Investigative Site

Boston, Massachusetts, 02114, United States

RECRUITING

Investigative Site

Rochester, Minnesota, 55905, United States

RECRUITING

Investigative Site

New York, New York, 10021, United States

RECRUITING

Investigative Site

Canton, Ohio, 44718, United States

RECRUITING

Investigative Site

Portland, Oregon, 97239, United States

RECRUITING

Investigative Site

Houston, Texas, 77030, United States

NOT YET RECRUITING

Investigative Site

Clichy, Île-de-France Region, 92110, France

RECRUITING

Investigative Site

Rotterdam, South Holland, 3015, Netherlands

NOT YET RECRUITING

Investigative Site

Basel, Canton Basel-Stadt, CH-4001, Switzerland

RECRUITING

Investigative Site

Saint Johns Wood, London, NW3 2QG, United Kingdom

NOT YET RECRUITING

Investigative Site

Withington, Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

FibrosarcomaHyperinsulinismHypoglycemiaNeoplasmsInsulinomaAdenoma, Islet CellLiposarcomaNeuroendocrine TumorsNeuroectodermal Tumors, Primitive

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeSarcomaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAdenomaNeoplasms, Glandular and EpithelialPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplasms, Adipose TissueNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplasms, Neuroepithelial

Central Study Contacts

Rezolute Clinical Trial

CONTACT

650-206-4507clinicaltrials@rezolutebio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 18, 2025

Study Start

April 16, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

GB(2)CH(1)FR(1)NL(1)US(8)