Ersodetug for Hyperinsulinism

(Tumor HI Trial)

Recruiting at 3 trial locations

Overseen By Rezolute Clinical Trial

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rezolute

Disqualifiers: Active infection, Organ condition, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called ersodetug to determine its effectiveness in managing low blood sugar levels in individuals with a specific type of tumor that produces excess insulin or insulin-like substances. The goal is to evaluate how well this treatment works alongside standard therapies and to ensure its safety for use. Suitable candidates have neuroendocrine tumors that cause low blood sugar and require IV glucose or nutrition for at least a week. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that significant changes to standard medical treatments for hypoglycemia should not occur within 4 weeks of screening or during the study. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that ersodetug is likely to be safe for humans?

Research has shown that ersodetug is under study for its safety and effectiveness in treating low blood sugar caused by tumor-related insulin issues. Although specific safety details from these studies aren't provided, its progression to a Phase 3 trial suggests promise in earlier research stages. Phase 3 indicates that the treatment has been tested in larger groups, with no major safety issues identified so far.

Ersodetug has also received Orphan Drug status from the FDA, which often indicates potential for treating rare conditions and suggests a positive safety profile based on current data. In summary, while specific side effects aren't listed, advancing to this trial phase and FDA recognition suggest it is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hyperinsulinism?

Ersodetug is unique because it targets hyperinsulinism by specifically tackling insulin- or IGF-producing tumors. Unlike traditional treatments that often focus on managing symptoms through medications or surgery, Ersodetug directly addresses the source of the issue by inhibiting the production of excessive insulin or IGF at the tumor level. Researchers are excited about Ersodetug because it offers a more targeted approach, potentially leading to better management of the condition and reducing the need for more invasive interventions.

What evidence suggests that ersodetug might be an effective treatment for Tumor Hyperinsulinism?

Research shows that the drug ersodetug, which participants in this trial will receive, may help manage low blood sugar in people with tumor hyperinsulinism, a condition where tumors cause excessive insulin production. Previous studies have found that adding this drug to standard treatments can better control blood sugar levels. Ersodetug is considered promising because it specifically targets insulin-producing tumors. It has received "orphan drug" status, indicating potential for treating this rare condition. While ongoing studies are needed for more information, early results suggest it could be a helpful addition to current treatments. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults over 18 with Tumor-Associated Hyperinsulinism (tHI) who often have low blood sugar despite standard treatments and surgery. They must be evaluated by a team including an oncologist and experience at least 3 significant hypoglycemia events weekly.

Inclusion Criteria

My eligibility was reviewed by a team of cancer specialists.

I am in a group receiving a hidden treatment as part of my study.

I experience 3 or more serious low blood sugar events weekly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive either ersodetug or placebo for 8 weeks

8 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with ersodetug long-term

up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Ersodetug

Trial Overview The trial is testing Ersodetug, a new medication for managing low blood sugar in patients with tHI, against a placebo to see if it's effective and safe. Participants are randomly assigned to receive either the drug or placebo.

How Is the Trial Designed?

Group I: Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Rezolute

Lead Sponsor

Trials

4

Recruited

230+

Citations

1. ir.rezolutebio.com ir.rezolutebio.com/news/detail/361/rezolute-announces-alignment-with-fda-on-streamlined-design-for-ongoing-phase-3-trial-of-ersodetug-in-tumor-hyperinsulinism

Rezolute Announces Alignment with FDA on Streamlined ... Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06881992

NCT06881992 | A Phase 3 Study of Ersodetug in Patients ... 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 ...

3. targetedonc.com targetedonc.com/view/fda-streamlines-pathway-for-ersodetug-in-tumor-hyperinsulinism

FDA Streamlines Pathway for Ersodetug in Tumor ... Rezolute streamlines the clinical pathway for ersodetug, expediting treatment for tumor hyperinsulinism and addressing urgent patient needs.

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-ersodetug-for-patients-with-uncontrolled-low-blood-sugar-due-to-tumor-related-high-insulin-levels/

Study on Ersodetug for Patients with Uncontrolled Low ... This study investigates tumor-associated hyperinsulinism (tumorHI), a condition where tumors cause excessive insulin production leading to ...

5. endocrinologyadvisor.com endocrinologyadvisor.com/news/ersodetug-designated-orphan-drug-for-hypoglycemia-due-to-tumor-hyperinsulinism/

Ersodetug Designated Orphan Drug for Hypoglycemia Due ... The randomized, double-blind, placebo-controlled trial will enroll 24 patients who have inadequately controlled hypoglycemia due to tumor HI.

6. empr.com empr.com/news/ersodetug-designated-orphan-drug-for-hypoglycemia-due-to-tumor-hyperinsulinism/

Ersodetug Designated Orphan Drug for Hypoglycemia Due ... The FDA has granted Orphan Drug designation to ersodetug (RZ358) for the treatment of hypoglycemia due to tumor hyperinsulinism.

7. sec.gov sec.gov/Archives/edgar/data/1509261/000110465925085892/tm2524786d1_ex99-1.htm

99.1 Tumor hyperinsulinism (HI) is a rare disease that may be caused by two distinct types of tumors: islet cell tumors (ICTs) and non-islet cell ...