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New treatment option for Tumor Hyperinsulinism (Tumor HI)
Official title A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
ClinicalTrials.gov ID: NCT06881992
What this study is testing
What is Ersodetug?
Ersodetug is an investigational medicine, given as an once-weekly, being studied as a potential treatment for tumor hyperinsulinism (tumor hi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to...
You likely can't join if
- 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...
- Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or...
- 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...
- Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is \<8 weeks.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Boston, Massachusetts, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Canton, Ohio, United States
- Portland, Oregon, United States
- Houston, Texas, United States
- Clichy, Île-de-France Region, France
- Rotterdam, South Holland, Netherlands
- Basel, Canton Basel-Stadt, Switzerland
- Saint Johns Wood, London, United Kingdom
- Withington, Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Bethesda, Maryland, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States; New York, New York, United States; Canton, Ohio, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.