A Phase 3 Study Of Ersodetug In Patients With Tumor-Associated Hyperinsulinism

Study Overview

A Phase 3 Study of Ersodetug in Patients With Tumor-Associated Hyperinsulinism

The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug for treatment of hypoglycemia in patients with Tumor-Associated Hyperinsulinism (tHI).

This study will include participants who are suffering from low blood sugar (hypoglycemia) related symptoms due to over-production (too much) of hormones (e.g. insulin or similar substances) by certain tumors that cannot be treated satisfactorily with available treatment. The study is divided into 3 periods: Screening (up to 4 weeks), Treatment (8 weeks) and either Follow-up (4 weeks) or optional Open Label Extension (OLE) phase (up to 3 years). Overall, the study will enroll about 48 participants. Participants will be assigned to the appropriate treatment group depending on the type of tumor and whether they are hospitalized or not. For those not hospitalized, participants will be assigned in random order to either receive ersodetug or placebo (substance that looks like the study drug but does not contain active study drug) for the 8-week treatment period. All patients will receive ersodetug in the optional OLE period. The study will be comprised of the following treatment groups: * Not hospitalized (referred to as ambulatory) insulin secreting tumor participants who receive usual treatment/standard of care therapies (SOC) and 9 mg/kg of ersodetug * Ambulatory insulin secreting tumor participants who receive SOC and placebo * Hospitalized (receiving IV dextrose or TPN ≥3 days) insulin or IGF secreting tumor participants who receive SOC and 9 mg/kg of ersodetug * Ambulatory IGF secreting tumor participants who receive SOC and 9 mg/kg of ersodetug Participants should continue to use pre-existing anti-hypoglycemic medications and anti-tumor therapies throughout the study.

Tumor- Associated Hyperinsulinism

DRUG: Ersodetug
DRUG: Ersodetug
DRUG: Placebo

RZ358-302

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-08-14
First Submitted that Met QC Criteria 2025-03-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-08-15
First Posted (ACTUAL) 2025-03-18	Results First Posted N/A	Last Verified 2025-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
PLACEBO_COMPARATOR: Double Blind Ambulatory Participants	DRUG: Ersodetug Ersodetug (9 mg/kg) + SOC DRUG: Placebo Placebo (9mg/kg) + SOC
OTHER: Open-Label Hospitalized Participants	DRUG: Ersodetug Ersodetug (9 mg/kg) + SOC

Participant Group/Arm

Intervention/Treatment

PLACEBO_COMPARATOR: Double Blind Ambulatory Participants

DRUG: Ersodetug

Ersodetug (9 mg/kg) + SOC

DRUG: Placebo

Placebo (9mg/kg) + SOC

OTHER: Open-Label Hospitalized Participants

DRUG: Ersodetug

Ersodetug (9 mg/kg) + SOC

Primary Outcome Measures	Measure Description	Time Frame
Double-Blind (Ambulatory participants):	Percent change from baseline in average weekly count of aggregate Level 2 (<54 mg/dL [<3 mmol/L] by SMBG) and adjudicated Level 3 hypoglycemia events during the entire pivotal treatment period.	8 weeks
Open-Label Arm (Hospitalized Participants):	Number of participants with clinically meaningful reduction (≥50%) in glucose infusion rate from baseline.	8 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Double-Blind (Ambulatory participants):	Change in average daily percent time below the certain blood glucose range by continuous glucose monitoring device through Weeks 1-8 of the treatment period.	8 weeks
Open-Label Arm (Hospitalized Participants):	• Change in average daily IV glucose/dextrose infusion rate (GIR).	8 weeks
Open-Label Arm (Hospitalized Participants):	• Change in average daily amount of total IV glucose (mg) during the pivotal treatment period.	8 weeks
Open-Label Arm (Hospitalized Participants):	• Time to complete stopping of IV glucose after the first ersodetug dose.	8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Rezolute Clinical Trial

Phone Number: 650-206-4507

Email: clinicaltrials@rezolutebio.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
Participants with a clinical diagnosis and laboratory confirmation of ICT or NICT, with associated hypoglycemia that is considered refractory to surgery and to usual SOC anti-hypoglycemia therapies, per investigator judgement.
Experiencing an average of ≥ 3 hypoglycemia events per week that meet Level 2 criteria and/or Level 3 criteria during the two weeks before randomization

Participants who have not previously received tumor-directed therapy (including at least one course/trial of systemic tumor-directed therapy, as appropriate) but are considered appropriate for tumor-directed therapies by the investigator and/or a multi-disciplinary oncology care team.
Initiation of, or changes to tumor directed therapies within 8 weeks prior to initiation of study drug, or expected initiation or significant changes to these therapies over the course of the pivotal treatment period
Initiation of, or significant changes to, SOC medical (e.g. diazoxide, SSAs, continuous glucagon, mTOR-Inhibitors, etc.) or supplemental enteral treatments (e.g. continuous tube feeds) used for the chronic management of hypoglycemia within 4 weeks of screening (per investigator's discretion), or expected changes to SOC medical therapies over the course of the pivotal treatment period.
Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator.

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 tHI confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.
Requiring IV glucose infusion and/or parenteral nutrition for ≥3 days for management of uncontrolled hypoglycemia

Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).
Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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