A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

Official record

Identifier

NCT06881992

Recruiting locations

countries

United StatesFranceNetherlandsSwitzerlandUnited Kingdom

Interventions studied

Ersodetug

Lead sponsor

Rezolute

Target enrolment

16 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Mar 18, 2025

Last updated on the registry

Sep 28, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Pancreatic Cancer