Expanded Access Program for Ersodetug in Patients with Uncontrolled Low Blood Sugar Due to Tumors

Sponsor: Rezolute

Expanded Access
Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07262970

Provider View

This program provides access to the investigational drug ersodetug for patients who have low blood sugar caused by tumors and cannot join a clinical trial for this drug. Eligible patients will be determined by their doctor.

Patient Parameters

Program Overview

This program is designed to offer the investigational drug ersodetug to patients who experience low blood sugar (hypoglycemia) that is not well controlled due to tumors that cause excessive insulin production. It is intended for patients who cannot participate in a clinical trial for ersodetug but meet the eligibility criteria and are considered suitable for the drug by their doctor.

Eligibility Criteria

Inclusion Criteria

  • Have low blood sugar due to a tumor that produces insulin or similar substances, which is not controlled by standard treatments.
  • Cannot join any clinical trial for ersodetug.
  • Women who can become pregnant must not be pregnant or breastfeeding and must agree to use birth control or abstain from sex during the program and for 5 months after the last dose.
  • Men with partners who can become pregnant must agree to use birth control or abstain from sex during the program and for 5 months after the last dose.

Exclusion Criteria

  • Have any unexplained significant lab results (other than glucose) that could affect safety, unless related to the disease and approved by a medical monitor.
  • Have an active infection like HIV, hepatitis B, or hepatitis C.
  • Have an allergy to ersodetug or its ingredients.
  • Have taken another investigational drug or used an investigational device recently, unless approved by a doctor and medical monitor.
  • Have any condition or disease that could interfere with the program or pose a risk, such as severe mental illness, alcoholism, drug abuse, or serious heart, liver, or kidney disease.

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