Recruiting
Phase 3

Ersodetug

Sponsor:

Rezolute

Code:

NCT06881992

Conditions

Tumor Hyperinsulinism (Tumor HI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ersodetug

Study Details

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).

Conditions

Tumor Hyperinsulinism (Tumor HI)

Study ID

NCT06881992

Start date

Apr 16, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Ersodetug

Ersodetug (9 mg/kg) + SOC

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Rezolute Clinical Trial

650-206-4507clinicaltrials@rezolutebio.com

Locations

Investigative Site

Recruiting

Chicago, Illinois, United States, 60637

Investigative Site

Recruiting

Bethesda, Maryland, United States, 20892

Investigative Site

Recruiting

Boston, Massachusetts, United States, 02114

Investigative Site

Recruiting

Rochester, Minnesota, United States, 55905

Investigative Site

Recruiting

New York, New York, United States, 10021

Investigative Site

Recruiting

Canton, Ohio, United States, 44718

Investigative Site

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Rezolute

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Rezolute on 2026-08-17.