Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06884618
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 345}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-05-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-03-18', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage I: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 40 months'}, {'measure': 'Stage I: Number of Participants With Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Up to Day 21'}, {'measure': 'Stage II: Objective Response Rate (ORR) as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)', 'timeFrame': 'Up to approximately 40 months'}], 'secondaryOutcomes': [{'measure': 'Plasma Concentrations of RO7673396 and its Metabolite(s)', 'timeFrame': 'Up to approximately 49 months'}, {'measure': 'Stage I: ORR as Assessed by the Investigator per RECIST V1.1', 'timeFrame': 'Up to approximately 49 months'}, {'measure': 'Stage I and II: Duration of Response (DOR) as Assessed by the Investigator per RECIST V1.1', 'timeFrame': 'Up to approximately 49 months'}, {'measure': 'Stage I and II: Progression-free Survival (PFS) as Assessed by the Investigator per RECIST V1.1', 'timeFrame': 'Up to approximately 49 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RAS Mutated Solid Tumors'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and tolerability of RO7673396 in participants with advanced solid tumors harboring RAS mutation(s). This study consists of two stages: Stage 1 (Dose Escalation) and Stage 2 (Dose Expansion). Stage 1 will define the recommended dose(s) for expansion (RDEs) of RO7673396. Stage 2 will evaluate preliminary anti-tumor activity of the RDE(s) defined in Stage 1 and of other doses of interest for future development in selected solid tumor indications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors\n* Participants with measurable disease according to RECIST v1.1 assessed by the investigator\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy ≥12 weeks\n* Adequate hematologic and end-organ function\n* Confirmed presence of the RAS mutation(s)\n\nExclusion Criteria:\n\n* Current participant or enrollment in another interventional clinical trial\n* Known hypersensitivity or medical contraindication to any component of RO7673396 formulation\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption\n* Known and untreated, or active central nervous system (CNS) metastases\n* Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease\n* Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment\n* Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Known clinically significant liver disease'}, 'identificationModule': {'nctId': 'NCT06884618', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of RO7673396 as a Single Agent and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Harboring RAS Mutation(s)', 'orgStudyIdInfo': {'id': 'YO45758'}, 'secondaryIdInfos': [{'id': '2024-519622-20-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage I', 'description': 'Participants with advanced solid tumors harboring RAS mutations will receive multiple ascending doses of RO7673396, as per a pre-defined dosing regimen until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.', 'interventionNames': ['Drug: RO7673396']}, {'type': 'EXPERIMENTAL', 'label': 'Stage II', 'description': 'Participants with advanced solid tumors harboring RAS mutations will receive RO7673396 at the dose determined in Stage 1, until unacceptable toxicity or disease progression and/or loss of clinical benefit as determined by the investigator.', 'interventionNames': ['Drug: RO7673396']}], 'interventions': [{'name': 'RO7673396', 'type': 'DRUG', 'description': 'RO7673396 will be administered as per the schedule specified in the protocol.', 'armGroupLabels': ['Stage I', 'Stage II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Colorado - Anschutz Medical Campus - PPDS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06519-1110', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Smilow Cancer Hospital at Yale New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Sarasota (North Catttlemen Rd)', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '77030-3721', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229-4427', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics (START)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Center', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '510555', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sun Yat-Sen University Cancer Center - Huangpu Campus', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sun yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '201315', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '430079', 'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hubei Cancer Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '1010', 'city': 'Auckland', 'status': 'RECRUITING', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research - Auckland', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8011', 'city': 'Christchurch', 'status': 'RECRUITING', 'country': 'New Zealand', 'facility': 'New Zealand Clinical Research - Christchurch', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '168583', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'National Cancer Centre - 30 Hospital Blvd', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '70403', 'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10002', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Reference Study ID Number: YO45758 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728 (U.S.)'}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}