ClinicaliQ Trial Snapshot
- A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism — Recruiting • Phase III • Oncology • NCT06881992.
- Being tested: Ersodetug as an add-on therapy to standard care for managing hypoglycemia in patients with Tumor Hyperinsulinism, with evaluation of glycemic control, safety, and tolerability in a Phase 3 trial.
- Patient eligibility overview: Adults with Tumor Hyperinsulinism experiencing hypoglycemia despite current standard of care therapy are eligible; specific inclusion/exclusion criteria would be detailed in the full protocol.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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).
Eligibility Snapshot
- : * 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).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.