A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism

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 …