Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-14 @ 8:20 AM
Study NCT ID:
NCT05595460
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2022-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 49}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2022-09-16', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RP2D', 'timeFrame': '42 days of study treatment', 'description': 'RP2D as determined by incidence rate of DLTs'}, {'measure': 'Safety and tolerability of RYZ101 in combination with SoC', 'timeFrame': 'Up to 50 months', 'description': 'Safety and tolerability of RYZ101 in combination with SoC as measured by incidence and severity of AEs including SAEs, laboratory changes and other safety findings'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['actinium', 'alpha-emitter', 'SSTR+ ES-SCLC', 'SCLC', 'ES-SCLC', 'RYZ101', '225Ac', '225Ac-DOTATATE', 'targeted radiotherapy', 'atezolizumab', 'carboplatin', 'etoposide', 'radiopharmaceutical'], 'conditions': ['SCLC,Extensive Stage']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Age of at least 18 years at the time of signing the informed consent.\n* Cytologically or histologically confirmed ES-SCLC (American Joint Committee on Cancer \\[AJCC\\] 8th edition) and is untreated or received ≤1 cycle of platinum-etoposide and PD-L1 inhibitor therapy. It is acceptable to omit the first dose of PD-L1 inhibitor therapy due to logistical reasons if receiving SoC during or prior to the start of the screening period.\n* Subject is a candidate for therapy with SoC which includes:\n\n * Carboplatin for a maximum of 4 cycles\n * Etoposide for a maximum of 4 cycles\n * Atezolizumab\n* At least 1SSTR-PET imaging-positive measurable site of disease (according to RECIST v1.1) and ≥50% of RECIST v1.1 measurable metastatic lesions must be SSTR-imaging positive.\n* Adequate hematologic, renal and hepatic function\n\nEXCLUSION CRITERIA\n\n* Prior exposure to immune-mediated therapy,\n* Known active or suspected autoimmune disease or any condition requiring systemic treatment with immunosuppressive medications within 14 days prior to first dose of study drug\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. Note: History of radiation pneumonitis is permitted.\n* Severe infection within 4 weeks and/or treatment with therapeutic oral or i.v. antibiotics within 2 weeks prior to initiation of study treatment.\n* Prior allogeneic stem cell or solid organ transplantation.\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab.\n* Radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy. Radiation therapy outside of the chest for palliative care is allowed but must be completed \\>2 weeks prior to first dose of study drug.\n* Significant cardiovascular disease and/or resistant hypertension\n* Subjects with previously treated central nervous system (CNS) metastases who have not recovered from acute side effects of radiotherapy.'}, 'identificationModule': {'nctId': 'NCT05595460', 'briefTitle': 'Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'RayzeBio, Inc.'}, 'officialTitle': 'Phase 1b Single Arm, Open-label Trial of RYZ101 in Combination With Carboplatin + Etoposide + Atezolizumab in Subjects With Somatostatin Receptor Expressing (SSTR+) Extensive Stage Small Cell Lung Cancer (ES-SCLC)', 'orgStudyIdInfo': {'id': 'RYZ101-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RYZ101 + SoC', 'interventionNames': ['Drug: RYZ101 Dose Level 1', 'Drug: RYZ101 Dose Level 2', 'Drug: RYZ101 Dose Level 3', 'Drug: RYZ101 Dose Level -1', 'Drug: Atezolizumab', 'Drug: Carboplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'RYZ101 Dose Level 1', 'type': 'DRUG', 'description': 'Dose Level 1', 'armGroupLabels': ['RYZ101 + SoC']}, {'name': 'RYZ101 Dose Level 2', 'type': 'DRUG', 'description': 'Dose Level 2', 'armGroupLabels': ['RYZ101 + SoC']}, {'name': 'RYZ101 Dose Level 3', 'type': 'DRUG', 'description': 'Dose Level 3', 'armGroupLabels': ['RYZ101 + SoC']}, {'name': 'RYZ101 Dose Level -1', 'type': 'DRUG', 'description': 'Dose Level -1', 'armGroupLabels': ['RYZ101 + SoC']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Atezolizumab', 'armGroupLabels': ['RYZ101 + SoC']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin', 'armGroupLabels': ['RYZ101 + SoC']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide', 'armGroupLabels': ['RYZ101 + SoC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact Gee', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Reserach Facility', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63130', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68130', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Research Facility', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '00935', 'city': 'San Juan', 'state': 'Puerto Rico', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Site Contact', 'role': 'CONTACT'}], 'facility': 'Research Facility', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'RayzeBio Clinical Trials', 'role': 'CONTACT', 'email': 'clinicaltrials@rayzebio.com', 'phone': '1-619-657-0057'}], 'overallOfficials': [{'name': 'Petrus De Jong, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RayzeBio, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RayzeBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}