Tumor-associated Hyperinsulinism (Tumor HI)NCT07262970
Intermediate-Size Cohort EAP for Ersodetug in Patients With Inadequately Controlled Hypoglycemia Related to a Tumor
A study testing Ersodetug (9 mg/kg) + SOC in people with Tumor-associated Hyperinsulinism (Tumor HI), run by Rezolute at 1 site in United States.
Trial summary
This expanded access program is intended to provide ersodetug, an investigational drug, to eligible participants who suffer from inadequately controlled hypoglycemia due to tumor-associated hyperinsulinism and are unable to participate in ersodetug clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor-associated Hyperinsulinism (Tumor HI)
- What is being tested?
- Ersodetug (9 mg/kg) + SOC
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Uncontrolled hypoglycemia due to documented tumor HI (including but not limited to: insulin/pro-insulin producing pancreatic/non-pancreatic neuroendocrine tumors, insulin-like growth factor-producing NICTH) that is not adequately managed with available SoC anti-hypoglycemic therapies (per Treating Physician's judgement).
- Inability to participate in any ersodetug clinical trial.
- Women of childbearing potential (WOCBP) must not be pregnant or breast feeding, and must be willing to use effective contraceptive measures or practice complete sexual abstinence to prevent pregnancy for the duration of the Cohort EAP AND for at least 5 months after receiving the last dose of ersodetug.
- Male participants with female partner of childbearing potential must be willing to use effective contraceptive measures or practice complete sexual abstinence to prevent pregnancy for the duration of the Cohort EAP AND for at least 5 months after receiving the last dose of ersodetug.
Who cannot join
- Any unexplained out-of-range laboratory value (other than glucose) that is assessed as clinically significant impacting patient safety if enrolled by the Treating Physician. Laboratory or other abnormalities that are considered related to the underlying disease or associated therapies that do not pose additional safety risk for participation per Treating Physician may be allowed upon Medical Monitor approval.
- Evidence of active infection including (but not limited to) human immunodeficiency virus, hepatitis B, or hepatitis C.
- Known allergy or sensitivity to ersodetug or any component of the drug.
- Treatment with an investigational drug or device within 30 days or 5 t½ of the investigational drug before the planned 1st dose of ersodetug, whichever is longer. However, if the Treating Physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit to outweigh the risk, then the participant may be allowed to participate. Participation in registries and/or purely diagnostic studies are allowed.
- Any organ condition, concomitant disease (including but not limited to any psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the program (e.g., may affect absorption, distribution, metabolism, or elimination of the program drug) or that, in the opinion of the Treating Physician and/or Medical Monitor would pose an unacceptable risk to the participant in the program.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Investigative Site
New Orleans, Louisiana, 70112
About this study
Official title: Intermediate-Size Cohort EAP for Ersodetug in Patients With Refractory Hypoglycemia Due to Tumor-Associated Hyperinsulinism (Tumor HI) Who Are Unable to Participate in a Clinical Trial
This expanded access program is intended to provide ersodetug, an investigational drug, to eligible participants who suffer from inadequately controlled hypoglycemia due to tumor-associated hyperinsulinism and are unable to participate in ersodetug clinical trial. Participation is open to participants who meet the eligibility criteria and for whom access to the investigational drug is deemed appropriate by the treating physician.
- Being tested
- Ersodetug (9 mg/kg) + SOC
- Keywords
- Insulinoma, Islet cell tumor (ICT), Ectopic insulinoma, Extra-pancreatic insulinoma, Pro-insulinoma, Non-islet cell tumor hypoglycemia (NICTH), Non Islet Cell Tumor, IGF 2 mediated non islet cell tumor hypoglycemia, IGF-oma, IGF-2-oma, Big IGF-2-oma, IGF-2, Big IGF-2, Neuroendocrine tumor (NET), PNET, Hypoglycemia, Paraneoplastic, Tumor/cancer associated hypoglycemia, Tumor/cancer induced hypoglycemia, Tumor/cancer mediated hypoglycemia, Hypoglycemia due to tumor/cancer, Doege-Potter Syndrome, Paraneoplastic hypoglycemia
- Medical subject headings
- Insulinoma, Adenoma, Islet Cell, Neuroendocrine Tumors, Neuroectodermal Tumors, Primitive, Hypoglycemia, Neoplasms, Hyperinsulinism, Liposarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ersodetug (9 mg/kg) + SOCDrug
Open-Label Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor-associated Hyperinsulinism (Tumor HI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Rezolute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262970
- Sponsor's protocol ID
- RZ358-303
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-Size Cohort EAP for Ersodetug in Patients With Refractory Hypoglycemia Due to Tumor-Associated Hyperinsulinism (Tumor HI) Who Are Unable to Participate in a Clinical Trial
- ClinicalTrials.gov ID
- NCT07262970
- Acronym / sponsor ID
- RZ358-303
- Keywords
- Insulinoma, Islet cell tumor (ICT), Ectopic insulinoma, Extra-pancreatic insulinoma, Pro-insulinoma, Non-islet cell tumor hypoglycemia (NICTH), Non Islet Cell Tumor, IGF 2 mediated non islet cell tumor hypoglycemia
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- RezoluteUniversity, hospital or other
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This expanded access program is intended to provide ersodetug, an investigational drug, to eligible participants who suffer from inadequately controlled hypoglycemia due to tumor-associated hyperinsulinism and are unable to participate in ersodetug clinical trial. Participation is open to participants who meet the eligibility criteria and for whom access to the investigational drug is deemed appropriate by the treating physician.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Uncontrolled hypoglycemia due to documented tumor HI (including but not limited to: insulin/pro-insulin producing pancreatic/non-pancreatic neuroendocrine tumors, insulin-like growth factor-producing NICTH) that is not adequately managed with available SoC anti-hypoglycemic therapies (per Treating Physician's judgement).
- Inability to participate in any ersodetug clinical trial.
- Women of childbearing potential (WOCBP) must not be pregnant or breast feeding, and must be willing to use effective contraceptive measures or practice complete sexual abstinence to prevent pregnancy for the duration of the Cohort EAP AND for at least 5 months after receiving the last dose of ersodetug.
- Male participants with female partner of childbearing potential must be willing to use effective contraceptive measures or practice complete sexual abstinence to prevent pregnancy for the duration of the Cohort EAP AND for at least 5 months after receiving the last dose of ersodetug.
Key exclusion criteria (5 listed)
- Any unexplained out-of-range laboratory value (other than glucose) that is assessed as clinically significant impacting patient safety if enrolled by the Treating Physician. Laboratory or other abnormalities that are considered related to the underlying disease or associated therapies that do not pose additional safety risk for participation per Treating Physician may be allowed upon Medical Monitor approval.
- Evidence of active infection including (but not limited to) human immunodeficiency virus, hepatitis B, or hepatitis C.
- Known allergy or sensitivity to ersodetug or any component of the drug.
- Treatment with an investigational drug or device within 30 days or 5 t½ of the investigational drug before the planned 1st dose of ersodetug, whichever is longer. However, if the Treating Physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit to outweigh the risk, then the participant may be allowed to participate. Participation in registries and/or purely diagnostic studies are allowed.
- Any organ condition, concomitant disease (including but not limited to any psychiatric illness, severe alcoholism, or drug abuse, cardiac, hepatic, or kidney disease), or other abnormality that itself, or the treatment of which, could interfere with the conduct of the program (e.g., may affect absorption, distribution, metabolism, or elimination of the program drug) or that, in the opinion of the Treating Physician and/or Medical Monitor would pose an unacceptable risk to the participant in the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ersodetug (9 mg/kg) + SOCOpen-Label Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ersodetug (9 mg/kg) + SOC in people with Tumor-associated Hyperinsulinism (Tumor HI), run by Rezolute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rezolute Clinical Trial (650-206-4507, tHIEAP@rezolutebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.