Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ia: Number of Participants with Dose Limiting Toxicities (DLTs)', 'timeFrame': 'From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)'}, {'measure': 'Phase Ib: Number of Participants with DLTs', 'timeFrame': 'From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment)'}, {'measure': 'Phase Ia: Number of Participants with Treatment Emergent Adverse Events', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Phase Ib: Number of Participants with Treatment Emergent Adverse Events', 'timeFrame': 'Up to approximately 5 years'}], 'secondaryOutcomes': [{'measure': 'Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of RO7502175', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day1 and at multiple timepoints up to each follow-up visits (up to approximately 5 years)'}, {'measure': 'Phase Ia and Phase Ib: Objective Response Rate (ORR)', 'timeFrame': 'From Cycle 1(each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)'}, {'measure': 'Phase Ia and Phase Ib: Duration of Response (DOR)', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)'}, {'measure': 'Phase Ia and Phase Ib: Progression Free Survival (PFS)', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1, until disease progression, death, or end of study (up to approximately 5 years)'}, {'measure': 'Phase Ia and Phase Ib: Percentage of Participants With Anti-Drug Antibody (ADA) to RO7502175', 'timeFrame': 'From Cycle 1 (each cycle is 21 days) Day 1 and at multiple timepoints up to treatment discontinuation (up to approximately 5 years)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Locally Advanced or Metastatic Solid Tumors', 'NSCLC', 'HNSCC', 'Melanoma', 'TNBC', 'Esophageal Cancer', 'Gastric Cancer', 'Cervical Cancer', 'Colorectal Cancer', 'Urothelial Carcinoma', 'Clear Cell RCC', 'HCC']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of RO7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, triple-negative breast cancer (TNBC), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (CRC), urothelial carcinoma (UC), clear cell renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC). Participants will be enrolled in 2 stages: dose escalation and dose expansion.'}, '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* 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* Tumor Specimen availability\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of RO7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab\n* Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, 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 RO7502175 infusion\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* Active or history of autoimmune disease\n* Prior allogeneic stem cell or organ transplantation'}, 'identificationModule': {'nctId': 'NCT05581004', 'briefTitle': 'A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7502175 as a Single Agent and in Combination With Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'GO43860'}, 'secondaryIdInfos': [{'id': '2021-006708-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase Ia: Dose Escalation', 'description': 'Participants in successive cohorts will receive escalating doses of RO7502175, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: RO7502175']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ia: Expansion', 'description': 'Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ia Dose Escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: RO7502175']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ib: Dose Escalation', 'description': 'Participants in successive cohorts will receive escalating doses of RO7502175, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: RO7502175', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ib: Expansion', 'description': 'Participants with select solid tumors will receive a recommended dose of RO7502175, determined in Phase Ib Dose Escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: RO7502175', 'Drug: Atezolizumab', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'RO7502175', 'type': 'DRUG', 'description': 'RO7502175 will be administered as per the schedules specified in the respective arms.', 'armGroupLabels': ['Phase Ia: Dose Escalation', 'Phase Ia: Expansion', 'Phase Ib: Dose Escalation', 'Phase Ib: Expansion']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'description': 'Atezolizumab will be administered as per the schedules specified in the respective arms.', 'armGroupLabels': ['Phase Ib: Dose Escalation', 'Phase Ib: Expansion']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Pembrolizumab will be administered as per the schedules specified in the respective arms.', 'armGroupLabels': ['Phase Ib: Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists - Sarasota', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Washington University Medical Center, Division of Oncology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The West Clinic - Memphis (Union Ave)', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98229', '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': 'Kinghorn Cancer Centre', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Monash Health Monash Medical Centre', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Linear Clinical Research Ltd', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '2650', 'city': 'Edegem', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '4040', 'city': 'Herstal', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.66415, 'lon': 5.62346}}, {'zip': '2610', 'city': 'Wilrijk', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'GasthuisZusters Antwerpen', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'British Columbia Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Ottawa Hospital Regional Cancer Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1Z5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Sir Mortimer B Davis Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '124 62', 'city': 'Chaïdári', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'facility': "University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA", 'geoPoint': {'lat': 38.01135, 'lon': 23.66597}}, {'zip': '564 03', 'city': 'N. Efkapria-Pavlos Melas', 'state': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Papageorgiou General Hospital of Thessaloniki'}, {'zip': '115 27', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Sotiria Thoracic Diseases Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '9713 GZ', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'COMPLETED', 'country': 'South Korea', 'facility': 'Asan Medical Center - PPDS', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Samsung Medical Center - PPDS', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System - Clinical Trials Center Pharmacy', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08908', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'ICO l?Hospitalet ? Hospital Duran i Reynals', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'status': 'COMPLETED', 'country': 'Spain', 'facility': 'START MADRID_Hospital Universiario Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario 12 De Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29010', 'city': 'Málaga', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '46010', 'city': 'Valencia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '413 45', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '17176', 'city': 'Stokholm, Solna', 'status': 'RECRUITING', 'country': 'Sweden', 'facility': 'Karolinska Universitetssjukhuset Solna'}, {'zip': '807', 'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40201', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'facility': 'Chung Shan Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'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: GO43860 https://forpatients.roche.com/', 'role': 'CONTACT', 'email': 'global-roche-genentech-trials@gene.com', 'phone': '888-662-6728 (U.S. Only)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}