Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05487235
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2022-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Poland', 'Spain', 'Taiwan', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)'}, {'measure': 'Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results', 'timeFrame': 'Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)'}, {'measure': 'Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)', 'timeFrame': 'Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)'}, {'measure': 'Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)', 'timeFrame': 'From Day 1 to Day 21 of Cycle 1 of the dose finding stage'}, {'measure': 'Plasma Concentration of GDC-1971', 'timeFrame': 'Up to approximately 2.5 years'}], 'secondaryOutcomes': [{'measure': 'Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Cmax of GDC-1971 Following Capsule or Tablet Administration', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'PFS Rate', 'timeFrame': 'Month 6'}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': 'Months 6 and 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors', 'Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of GDC-1971 when administered in combination with atezolizumab in participants with locally advanced or metastatic solid tumors.\n\nThe study will have 2 stages- dose finding stage and expansion stage. In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high (NSCLC PD L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinoma (HNSCC) PD L-1 positive, BRAF wild type (BRAF WT) melanoma and any locally advanced or metastatic solid tumors will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1\n* Has Life expectancy \\>= 12 weeks\n* Adequate organ function\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).\n\nInclusion Criteria for Dose-Finding Stage:\n\n* Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable\n\nInclusion Criteria for Expansion Stage: NSCLC Cohort\n\n* Histologically confirmed locally advanced or metastatic NSCLC\n* Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK)\n* PD- L1 positive\n* No prior systemic therapy for locally advanced or metastatic NSCLC\n\nInclusion Criteria for Expansion Stage: HNSCC Cohort\n\n* Histologically confirmed recurrent, or metastatic HNSCC\n* PD-L1 positive\n* No prior systemic therapy for recurrent or metastatic HNSCC\n\nInclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort\n\n* Histologically confirmed locally advanced or metastatic or unresectable locally advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are non-mucosal and non -uveal that has progressed on or after treatment that included anti PD1 or anti PD-L1 therapy\n\nInclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort\n\n* Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable, standard therapy is considered inappropriate, or an investigational agent is a recognized standard of care\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.\n* Has leptomeningeal disease or carcinomatous meningitis\n* Has uncontrolled hypertension\n* Has left ventricular ejection fraction \\< institutional lower limit of normal or \\< 50%\n* Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Has an active or history of autoimmune disease or immune deficiency including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis. Participants with a history of autoimmune- related hypothyroidism on thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study"}, 'identificationModule': {'nctId': 'NCT05487235', 'briefTitle': 'A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ib, Open-Label Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'GO43712'}, 'secondaryIdInfos': [{'id': '2021-006479-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-finding Stage: GDC-1971', 'description': 'Participants will receive GDC-1971 tablet or capsule at assigned dose, orally once daily (QD) on Days 1-21 of each cycle, along with atezolizumab 1200 milligrams (mg) intravenous (IV) infusion once every 3 weeks (Q3W), until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet versus (vs) capsule formulations.', 'interventionNames': ['Drug: GDC-1971', 'Drug: Atezolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Expansion Stage: GDC-1971', 'description': 'Participants will receive GDC-1971 orally at the assigned dose QD on Days 1-21 of each cycle and atezolizumab 1200 mg IV on Day 1 of each cycle until unacceptable toxicity or loss of clinical benefit. A subset of participants will participate in evaluations regarding tablet vs capsule formulation, the effect of food and acid-reducing agents on GDC-1971.', 'interventionNames': ['Drug: GDC-1971', 'Drug: Atezolizumab', 'Drug: Omeprazole']}], 'interventions': [{'name': 'GDC-1971', 'type': 'DRUG', 'otherNames': ['RO7517834, RLY-1971'], 'description': 'Capsule or tablet administered orally.', 'armGroupLabels': ['Dose-finding Stage: GDC-1971', 'Expansion Stage: GDC-1971']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['RO5541267'], 'description': 'Administered as IV infusion.', 'armGroupLabels': ['Dose-finding Stage: GDC-1971', 'Expansion Stage: GDC-1971']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Administered orally as tablet or capsule in the acid-reducing agent assessment.', 'armGroupLabels': ['Expansion Stage: GDC-1971']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'X5000JHQ', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Sanatorio Allende', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'F5300COE', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Fundacion CORI para la Investigacion y Prevencion del Cancer', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': 'S2013SBK', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'Centro Medico IPAM', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital Sydney", 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3690', 'city': 'Wodonga', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Border Medical Oncology'}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Hospital', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'One Clinical Research Perth', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '81520-060', 'city': 'Curitiba', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner'}, {'zip': '90035-903', 'city': 'Pôrto Alegre', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre HCPA PPDS', 'geoPoint': {'lat': -4.98333, 'lon': -56.6}}, {'zip': '98700-000', 'city': 'Ijuí', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'ONCOSITE Centro de Pesquisa Clínica Em Oncologia', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'zip': '14784-400', 'city': 'Barretos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundacao Pio XII Hospital de Cancer de Barretos', 'geoPoint': {'lat': -20.55722, 'lon': -48.56778}}, {'zip': '17210-080', 'city': 'Jaú', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundação Doutor Amaral Carvalho - Hospital Amaral', 'geoPoint': {'lat': -22.29639, 'lon': -48.55778}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '01246-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de Sao Paulo - ICESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '03102-006', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Brasileiro de Controle Do Câncer IBCC', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '28644', 'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}, {'zip': '10408', 'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center - PPDS', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], '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': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}