Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
Study NCT ID:
NCT06881992
Status:
RECRUITING
Last Update Posted:
2025-10-21
First Post:
2025-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007340', 'term': 'Insulinoma'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}, {'id': 'D008080', 'term': 'Liposarcoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}], 'ancestors': [{'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018205', 'term': 'Neoplasms, Adipose Tissue'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-14', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with clinically meaningful reduction in IV glucose infusion rate from baseline.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in average daily IV glucose/dextrose infusion rate (GIR).', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline in average daily total IV glucose delivery (g)', 'timeFrame': '8 weeks'}, {'measure': 'Time to complete weaning off IV glucose administration after initiating ersodetug.', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Doege-Potter Syndrome', 'Ectopic insulinoma', 'Extra-pancreatic insulinoma', 'Fibrosarcoma', 'HCC', 'Hyperinsulinemia', 'Hypoglycemia', 'Hypoglycemia due to fibrosarcoma', 'Hypoglycemia due to HCC', 'Hypoglycemia due to liposarcoma', 'Hypoglycemia due to tumor/cancer', 'IGF 2 Insulinoma', 'IGF 2 mediated non islet cell tumor hypoglycemia', 'IGF-2 mediated hypoglycemia', 'IGF-2, Big IGF-2', 'IGF-oma, IGF-2-oma, Big IGF-2-oma', 'Insulinoma', 'Islet cell tumor (ICT)', 'Liposarcoma', 'Neuroendocrine tumor (NET)', 'NICTH', 'Non Islet Cell Tumor', 'Non-islet cell tumor hypoglycemia (NICTH)', 'Paraneoplastic', 'Paraneoplastic hypoglycemia', 'PNET', 'Pro-insulinoma', 'Tumor/cancer associated hypoglycemia', 'Tumor/cancer induced hypoglycemia', 'Tumor/cancer mediated hypoglycemia', 'Clinical Trials for: -Insulinoma -proinsulinoma -extrapancreatic insulinoma -non-islet cell tumor -IGF-oma -HCC -Liposarcoma -Fibrosarcoma'], 'conditions': ['Tumor Hyperinsulinism (Tumor HI)']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the glycemic efficacy, safety, and tolerability of ersodetug as add-on to standard of care (SOC) therapy for treatment of hypoglycemia in patients with Tumor Hyperinsulinism (Tumor HI).', 'detailedDescription': 'This study will include participants who are suffering from low blood sugar related symptoms (hypoglycemia) due to over-production of hormones (e.g. insulin or similar substances) by certain non-removable tumors that cannot be treated satisfactorily with available treatment. Every study participant will receive ersodetug doses weekly for 8 weeks alongside their usual treatments for hypoglycemia at a dose of 9 mg/kg.\n\nThe study is divided into 3 periods: Screening (up to 4 weeks), Treatment (8 weeks) and either End of Study Follow-up (approximately up to 20 weeks after the last dose) or optional Open Label Extension (OLE) phase (up to 3 years).\n\nThis study is being conducted at approximately 10-15 study sites in approximately 5 countries. The study will enroll approximately 16 participants, all with a diagnosis of tumor HI (insulin- or IGF producing tumors).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The eligibility criteria of all participants must be evaluated by a multidisciplinary team led by the PI, which must include an oncologist\n* Male or female participants of ≥18 years of age who provide written informed consent.\n* Clinical diagnosis of neuroendocrine tumor (NET) (ICT or NICT) with biochemical evidence of tumor hyperinsulinism (hypoglycemia with inappropriately elevated insulin or insulin-like growth factor (IGF)/variant suppression) confirmed via laboratory assessment who have failed to achieve adequate control of hypoglycemia with usual SOC anti-hypoglycemic therapies, per investigator judgement.\n* Currently requiring IV glucose infusion and/or parenteral nutrition for ≥7 days for the management of refractory hypoglycemia (prior to administration of the 1st dose of ersodetug).\n\nExclusion Criteria:\n\n* Evidence of active infection including human immunodeficiency virus, hepatitis B, or hepatitis C (excluding immunization patterns).\n* Treatment with an investigational drug or device within 30 days or 5 half-lives of the investigational drug (whichever is longer), however, if the treating physician and Medical Monitor consider no significant risk of drug-drug interaction and potential benefit outweighs the risk then the participant may be allowed to participate. Participation in registries and purely diagnostic studies is allowed\n* Any out-of-range laboratory value at screening (other than glucose) that is assessed as clinically significant by the investigator. Laboratory or radiographic abnormalities that are considered related to the underlying disease (tumor) or associated therapies and do not pose additional safety risk for study participation per investigator and Medical Monitor may be allowed.\n* Known allergy or sensitivity to ersodetug or any component of the drug.\n* 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.\n* Estimated life expectancy (additional lifespan) due to underlying disease (tumor) is \\<8 weeks."}, 'identificationModule': {'nctId': 'NCT06881992', 'acronym': 'Tumor HI', 'briefTitle': 'A Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism', 'organization': {'class': 'OTHER', 'fullName': 'Rezolute'}, 'officialTitle': 'A Phase 3, Single-Arm, Open-label, Pivotal Study to Evaluate the Efficacy and Safety of Ersodetug Compared to Baseline in Patients With Inadequately Controlled Hypoglycemia Due to Tumor Hyperinsulinism (Tumor HI)', 'orgStudyIdInfo': {'id': 'RZ358-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)', 'interventionNames': ['Drug: Ersodetug']}], 'interventions': [{'name': 'Ersodetug', 'type': 'DRUG', 'description': 'Ersodetug (9 mg/kg) + SOC', 'armGroupLabels': ['Participants with a diagnosis of Tumor HI (insulin- or IGF-producing tumors)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Rezolute Clinical Trial', 'role': 'CONTACT', 'email': 'clinicaltrials@rezolutebio.com', 'phone': '650-206-4507'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rezolute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}