Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-19 @ 8:08 AM
Study NCT ID:
NCT06590857
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2033-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation', 'timeFrame': '6 weeks of RYZ101 treatment', 'description': 'Incidence rate of DLTs during the first 6 weeks of RYZ101 treatment'}, {'measure': 'Expansion', 'timeFrame': 'Up to approximately 5 years after the last subject has completed RYZ101 treatment', 'description': 'Overall Response Rate, defined as rate of subjects achieving a Complete Response or Partial Response as determined by BICR using RECIST v1.1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Actinium', 'Alpha-Emitter', 'SSTR+ MBC', 'ER+, HER2-, MBC', 'RYZ101', '225Ac', 'Targeted Radiotherapy', 'Radiopharmaceutical', 'SSTR+ ABC', 'ER+, HER2-, ABC'], 'conditions': ['Metastatic Breast Cancer', 'HER2-negative Breast Cancer', 'ER+ Breast Cancer', 'Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nSubjects must meet all the following criteria for enrollment in the study:\n\n* Eastern Cooperative Oncology Group performance status ≤2.\n* Histologically confirmed, ER+, HER2-negative, locally advanced and unresectable or metastatic breast cancer not amenable to treatment with curative intent.\n* At least one RECIST v1.1-measurable tumor lesion that is SSTR-PET positive (defined as maximum standard uptake value (SUVmax) higher than liver mean standard uptake value (SUVmean) on SSTR-PET imaging) and at least 80% of RECIST v1.1measurable tumor lesions are SSTR-PET positive\n* Sufficient renal function, as evidenced by eGFR ≥60 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n* Adequate hematologic and hepatic function\n\nExclusion Criteria\n\nSubjects who meet any of the following criteria will be excluded from the study:\n\n* Prior radiopharmaceutical therapy, including radioembolization.\n* Any toxicities from prior treatments that have not recovered to CTCAE Grade ≤1, except for alopecia.\n* Significant cardiovascular disease\n* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, spinal cord compression, or leptomeningeal disease.\n* History of hypersensitivity or allergy to 225Ac, 68Ga, 64Cu, octreotate, or any of the excipients of DOTATATE imaging agents.\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the study safety or efficacy assessments.\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT06590857', 'acronym': 'TRACY-1', 'briefTitle': 'Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.', 'organization': {'class': 'INDUSTRY', 'fullName': 'RayzeBio, Inc.'}, 'officialTitle': 'Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects With Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates and/or Chemotherapy (TRACY-1).', 'orgStudyIdInfo': {'id': 'RYZ101-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'RYZ101 Dose Level -1\n\nRYZ101 Dose Level 1\n\nRYZ101 Dose Level 2\n\nRYZ101 Dose Level 3', 'interventionNames': ['Drug: RYZ101']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion', 'description': 'RYZ101 RP2D Regimen', 'interventionNames': ['Drug: RYZ101']}], 'interventions': [{'name': 'RYZ101', 'type': 'DRUG', 'description': 'Ac-225', 'armGroupLabels': ['Dose Escalation', 'Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92618', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80504', 'city': 'Longmont', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 40.16721, 'lon': -105.10193}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 33.749, 'lon': 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