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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ersodetug (9 mg/kg) + SOC | Drug | Open-Label Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rezolute Clinical Trial | Contact | 650-206-4507 | tHIEAP@rezolutebio.com |
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| ID | Term |
|---|---|
| D007340 | Insulinoma |
| D007516 | Adenoma, Islet Cell |
| D018358 | Neuroendocrine Tumors |
| D018242 | Neuroectodermal Tumors, Primitive |
| D007003 | Hypoglycemia |
| D009369 | Neoplasms |
| D006946 | Hyperinsulinism |
| D008080 | Liposarcoma |
| D005354 | Fibrosarcoma |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010190 | Pancreatic Neoplasms |
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| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018302 | Neoplasms, Neuroepithelial |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |