Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 2:43 PM
Study NCT ID:
NCT07165132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535650', 'term': 'Gastro-enteropancreatic neuroendocrine tumor'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D002276', 'term': 'Carcinoid Tumor'}, {'id': 'D007516', 'term': 'Adenoma, Islet Cell'}], 'ancestors': [{'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D000236', 'term': 'Adenoma'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2032-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation', 'timeFrame': 'Incidence of DLTs during the first 4 weeks of RYZ401 treatment', 'description': 'Incidence of DLTs during RYZ 401 Treatment'}, {'measure': 'Dose Expansion', 'timeFrame': 'Cycle1 Day 1 to LPFV + 6 weeks', 'description': 'Incidence, severity, and duration of AEs'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroendocrine Tumors', 'SSTR+', 'GEP-NET', 'Targeted Radiotherapy', 'Gastroenteropancreatic Neuroendocrine Tumor', 'RayzeBio', 'Actinium', 'Ac 225', 'PRRT', 'Solid Tumor', 'Somatostatin Receptors', 'Radiopharmaceutical'], 'conditions': ['GEP-NET', 'Gastroenteropancreatic Neuroendocrine Tumor', 'Gastroenteropancreatic Neuroendocrine Tumor Disease', 'Neuroendocrine Tumors', 'Carcinoid', 'Carcinoid Tumor', 'Pancreatic NET', 'Solid Tumor', 'Somatostatin Receptor']}, 'descriptionModule': {'briefSummary': 'The primary objectives are to determine the recommended Phase 2 dose (RP2D) and optimal treatment regimen, characterize safety and tolerability, and evaluate preliminary efficacy of RYZ401 in subjects with NETs and other selected solid tumors expressing SSTRs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* At least 18 years old at the time of signing the main study informed consent form (ICF).\n* Histologically confirmed:\n\n * Grades 1-3 WD NETs (dose escalation and dose expansion)\n * Meningioma (dose expansion only)\n* SSTR-positive disease, as assessed by SSTR-PET imaging\n* Adequate renal, hematologic and hepatic function\n\nExclusion criteria:\n\n* Prior RPT, including Lu-177.\n* Prior solid organ or bone marrow transplantation.\n* Use of chronic systemic steroid therapy.\n* Significant cardiovascular disease\n* Resistant hypertension\n* Uncontrolled diabetes\n* Prior history of liver cirrhosis\n* HIV, hepatitis B infection or known active hepatitis C virus infection.'}, 'identificationModule': {'nctId': 'NCT07165132', 'briefTitle': 'Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.', 'organization': {'class': 'INDUSTRY', 'fullName': 'RayzeBio, Inc.'}, 'officialTitle': 'Phase 1 First-in-Human (FIH), Dose Escalation and Dose Expansion Study of RYZ401, a Novel Radiopharmaceutical Therapy Labeled With Actinium-225 (225Ac), in Subjects With Neuroendocrine Tumors (NETs) and Other Selected Solid Tumors Expressing Somatostatin Receptors (SSTRs).', 'orgStudyIdInfo': {'id': 'RYZ401-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation, Dose Expansion', 'interventionNames': ['Drug: RYZ401']}], 'interventions': [{'name': 'RYZ401', 'type': 'DRUG', 'description': 'Ac-225', 'armGroupLabels': ['Dose Escalation, Dose Expansion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'RayzeBio Clinical Trials', 'role': 'CONTACT', 'email': 'clinicaltrials@rayzebio.com', 'phone': '+1 619 657 0057'}], 'overallOfficials': [{'name': 'Denis Ferreira, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RayzeBio, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RayzeBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}