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Study of Ersodetug for Tumor Hyperinsulinism

This study is testing a drug called ersodetug for people who have low blood sugar (hypoglycemia) caused by a tumor that produces too much insulin or similar hormones (tumor hyperinsulinism). You might be eligible if you are at least 18 years old, have this type of tumor, and your current treatments aren't working well enough. The study aims to see if ersodetug, given weekly for 8 weeks along with your usual care, can help reduce the amount of glucose (sugar) you need to keep your blood sugar stable. Researchers will measure this change after 8 weeks to see how effective ersodetug is. This study plans to enroll about 16 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 16 participants.
What's involved
You would receive weekly doses of ersodetug for 8 weeks. The study involves a screening period of up to 4 weeks, an 8-week treatment period, and a follow-up period of up to 20 weeks, or an optional open-label extension for up to 3 years.
Compensation
Not stated in the trial record.
Follow-up
After the 8-week treatment, there is an End of Study Follow-up period of approximately up to 20 weeks after the last dose, or an optional Open Label Extension phase for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06881992

A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Recruiting
PHASE3Ages 18+InterventionalTreatment
Rezolute
~16 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Ersodetug

At a glance

Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.
Measured over 8 weeks

Conditions

Tumor Hyperinsulinism (Tumor HI)

Explore related trials

FibrosarcomaHepatocellular CarcinomaLiposarcomaNeuroendocrine TumorPancreatic InsulinomaPancreatic Neuroendocrine TumorSolid NeoplasmInsulinInsulin-Like Growth Factor Receptor

Where it's being run

13 sites across 13 states
Illinois1
Maryland1
Massachusetts1
Minnesota1
New York1
Ohio1
Oregon1
Texas1

Who to contact

Rezolute Clinical Trial
[email protected]
650-206-4507
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.8 weeks