ClinicalTrials.gg
AvailableNCT07262970Updated Oct 7, 2026

Intermediate-Size Cohort EAP for Ersodetug in Patients With Inadequately Controlled Hypoglycemia Related to a Tumor

An expanded access record providing Ersodetug (9 mg/kg) + SOC in Tumor-associated Hyperinsulinism (Tumor HI), sponsored by Rezolute. Available at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Rezolute · Expanded access

Updated Oct 7, 2026First site in United States1 site addedGo to Updates ↓
Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tumor-associated Hyperinsulinism (Tumor HI)

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
  • Hyperinsulinemia
  • IGF-2 mediated hypoglycemia
  • HCC
  • Liposarcoma
  • Fibrosarcoma
  • Hypoglycemia due to HCC
  • Hypoglycemia due to liposarcoma
  • Hypoglycemia due to fibrosarcoma
  • Clinical Trials for: -Insulinoma -proinsulinoma -extrapancreatic insulinoma -non-islet cell tumor -IGF-oma -HCC -Liposarcoma -Fibrosarcoma
  • Expanded Access
  • Cohort Expanded Access
  • EAP
  • Pre-approval Access
  • Compassionate Use
  • Special Access Program
  • Named Patient Basis
  • Special Access Scheme
03

In context

Insulinoma

62 studies on the registry are indexed under Insulinoma; 12 are open to participants now.

Browse Insulinoma studies →

Lead sponsor

Rezolute is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 (WOCBP) must not be pregnant or breast feeding, and must be willing to use effective 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.

Exclusion criteria

Exclusion Criteria:

  • Any unexplained out-of-range laboratory value (other than glucose) that is assessed as 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) , , or .
  • Known allergy or sensitivity to ersodetug or any component of the drug.
  • Treatment with an 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • DrugErsodetug (9 mg/kg) + SOC

    Drug page: Ersodetug

    Open-Label Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)

06

Where to request access

1 of 1 sites recruiting
  • Investigative Site
    New Orleans, Louisiana 70112, United States
    Available
07

Updates

1 registry update since Sep 25, 2026
Sites
1 site added — first site in United States
Show site
  • Investigative Site · New Orleans, United States
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    1 site added — first site in United States
    Show site
    • Investigative Site · New Orleans, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

08

Registry details

Key details

Study ID
NCT07262970
Lead sponsor
Rezolute
Responsible party
Sponsor
First posted
Dec 4, 2025
Last update
Oct 7, 2026

Study contacts

Rezolute Clinical Trial
Contact
tHIEAP@rezolutebio.com
650-206-4507
View the source record on ClinicalTrials.gov ↗

Requesting access

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