Ersodetug treatment for patients with tumor-related low blood sugar
A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)
This study is testing a new treatment called ersodetug to see if it can help people with low blood sugar caused by certain tumors feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rezolute Academic / other |
| Locations | 13 sites (Chicago, Illinois and 12 other locations) |
| Trial ID | NCT06881992 on ClinicalTrials.gov |
What this trial studies
This phase 3 study evaluates the effectiveness, safety, and tolerability of ersodetug in treating hypoglycemia caused by tumor-associated hyperinsulinism. Participants will be assigned to receive either ersodetug or a placebo over an 8-week treatment period, depending on their hospitalization status and type of tumor. The study includes a screening phase, a treatment phase, and an optional open-label extension phase lasting up to 3 years. Approximately 48 participants will be enrolled, focusing on those with insulin or IGF-secreting tumors that have not responded to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of insulin or IGF-secreting tumors, experiencing frequent hypoglycemic events that are refractory to standard treatments.
Not a fit: Patients who have not previously received tumor-directed therapy or those whose hypoglycemia is manageable with existing treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve blood sugar control and quality of life for patients suffering from tumor-associated hyperinsulinism.
How similar studies have performed: While this approach is novel in the context of tumor-associated hyperinsulinism, similar studies targeting hypoglycemia in other contexts have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chicago, Illinois and 12 other locations
- Investigative Site — Chicago, Illinois, United States (Recruiting)
- Investigative Site — Bethesda, Maryland, United States (Not_yet_recruiting)
- Investigative Site — Boston, Massachusetts, United States (Recruiting)
- Investigative Site — Rochester, Minnesota, United States (Recruiting)
- Investigative Site — New York, New York, United States (Recruiting)
- Investigative Site — Canton, Ohio, United States (Recruiting)
- Investigative Site — Portland, Oregon, United States (Recruiting)
- Investigative Site — Houston, Texas, United States (Not_yet_recruiting)
- Investigative Site — Clichy, Île-de-France Region, France (Recruiting)
- Investigative Site — Rotterdam, South Holland, Netherlands (Not_yet_recruiting)
- Investigative Site — Basel, Canton Basel-Stadt, Switzerland (Recruiting)
- Investigative Site — Saint Johns Wood, London, United Kingdom (Not_yet_recruiting)
- Investigative Site — Withington, Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rezolute Clinical Trial
- Email: clinicaltrials@rezolutebio.com
- Phone: 650-206-4507
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.