Status:
RECRUITING
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Lead Sponsor:
Rezolute
Conditions:
Tumor Hyperinsulinism (Tumor HI)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Tum...
Detailed Description
This study will include participants who are suffering from low blood sugar related symptoms (hypoglycemia) due to over-production of hormones (e.g. insulin or similar substances) by certain non-remov...
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.
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06881992
Start Date
April 16 2025
End Date
September 1 2027
Last Update
December 30 2025
Active Locations (13)
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1
Investigative Site
Chicago, Illinois, United States, 60637
2
Investigative Site
Bethesda, Maryland, United States, 20892
3
Investigative Site
Boston, Massachusetts, United States, 02114
4
Investigative Site
Rochester, Minnesota, United States, 55905