Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06488716
Status:
TERMINATED
Last Update Posted:
2025-12-24
First Post:
2024-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Following a thorough review of safety data, preliminary efficacy data and an evaluation of overall risk-benefit, Sponsor made the decision to end the study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-06-20', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants iwth Dose Limiting Toxicity (DLTs)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 5 years'}], 'secondaryOutcomes': [{'measure': 'Maximum Serum Concentration (Cmax) of RO7759065', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to Approximately 5 Years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to RO7759065', 'timeFrame': 'Up to approximately 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumour']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7759065 as a single agent (Phase Ia) or in combination with atezolizumab (Phase Ib) in patients with locally advanced, recurrent, or metastatic incurable solid tumor malignancies. Several key aspects of the study design and study population are summarized below.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Life expectancy at least 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic and end-organ function\n* Measurable disease according to Response Evaluation criteria in Solid Tumors (RECIST) Version 1.1\n* Histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy\n* Availability of representative tumor specimens required for patients in select cohorts.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment\n* Active hepatitis B or C or tuberculosis\n* Positive test for human immunodeficiency virus (HIV) infection\n* Acute or chronic active Epstein-Barr virus (EBV) infection at screening\n* Administration of a live, attenuated vaccine (e.g., FluMist) within 4 weeks before first RO7759065 infusion\n* Primary, untreated, or active central nervous system (CNS) metastases\n* Active or history of autoimmune disease or immune deficiency\n* Prior allogeneic stem cell or organ transplantation\n* Any history of a Grade 3 immune-mediated adverse event attributed to prior cancer immunotherapy that resulted in permanent discontinuation of that agent\n* Any history of a Grade 4 immune-mediated adverse event attributed to prior cancer immunotherapy.'}, 'identificationModule': {'nctId': 'NCT06488716', 'briefTitle': 'A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ia/Ib, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7759065 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'GO45296'}, 'secondaryIdInfos': [{'id': '2024-513391-17-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase Ia: Dose Escalation', 'interventionNames': ['Drug: RO7759065']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ia: Expansion', 'interventionNames': ['Drug: RO7759065']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ib: Dose Escalation', 'interventionNames': ['Drug: RO7759065', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ib: Expansion', 'interventionNames': ['Drug: RO7759065', 'Drug: Atezolizumab']}], 'interventions': [{'name': 'RO7759065', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Phase Ia: Dose Escalation', 'Phase Ia: Expansion', 'Phase Ib: Dose Escalation', 'Phase Ib: Expansion']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Phase Ib: Dose Escalation', 'Phase Ib: Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80045-2517', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '37404-1130', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennesse Oncology - NASH - SCRI - PPDS', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': 'V5Z 4R2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5G 2MR', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sir Mortimer B Davis Jewish General Hospital-3755 Cote Sainte-Catherine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '28027', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra-Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}