Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 5:13 PM
Study NCT ID:
NCT05060432
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000719628', 'term': 'dostarlimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with DLT and Adverse Events', 'timeFrame': 'From first study treatment administration through Day 21-28 for DLT / Up to 120 days after the last dose'}, {'measure': 'Recommended Phase 2 dose (RP2D) of EOS884448 in participants with advanced solid tumors', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Percentage of participants with Objective Response as determined by Investigator', 'timeFrame': 'Until disease progression - Approximately 48 months'}], 'secondaryOutcomes': [{'measure': 'Duration of Response (DOR)', 'timeFrame': 'Until disease progression or death - Approximately 48 months'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Until disease progression or death - Approximately 48 months'}, {'measure': 'Progression-free-survival (PFS)', 'timeFrame': 'Until disease progression or death - Approximately 48 months'}, {'measure': 'Mean and median Maximum concentration (Cmax) of EOS884448 at each dose level', 'timeFrame': 'Up to 48 weeks'}, {'measure': 'Percentage of participants with anti-drug antibodies to EOS884448', 'timeFrame': 'Up to 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EOS884448', 'GSK4428859A', 'TIGIT', 'Anti-TIGIT', 'EOS-448', 'pembrolizumab', 'dostarlimab', 'inupadenant', 'A2A Receptor antagonist', 'EOS-850', 'EOS100850', 'Anti-PD-1 monoclonal antibody', 'belrestotug'], 'conditions': ['Advanced Cancer', 'Lung Cancer', 'Head and Neck Cancer', 'Melanoma']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.', 'detailedDescription': 'The combinations evaluated will be:\n\n* EOS-448 combined with pembrolizumab, an anti-PD-1 antibody\n* EOS-448 combined with inupadenant an investigational adenosine A2A receptor antagonist\n* EOS-448 combined with dostarlimab an anti-PD-1 antibody\n* inupadenant combined with dostarlimab\n* EOS-448 combined with inupadenant and dostarlimab\n* EOS-448 combined with dostarlimab and standard of care chemotherapies in participants with NSCLC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide a signed written informed consent for the trial\n* Have measurable disease, per RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.\n* Have adequate organ functions\n* Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available\n\nPart 1G (NSCLC):\n\n* Have a histologically confirmed or cytologically confirmed previously untreated stage IV OR stage III not amenable to curative chemoradiotherapy or surgery (AJCC 8th edition) nonsquamous NSCLC OR squamous NSCLC.\n* Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting\n\nPart 2 (H\\&N cancer)\n\n* Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies\n* PD-L1 status positive\n\nExclusion Criteria:\n\n* Have received any anti-cancer therapy within 4 weeks prior to the first dose\n* Have received a live vaccine within 30 days prior to the first dose\n* Have known primary CNS cancer.\n* Have known CNS metastases unless previously treated and well controlled for at least 1 month\n* Have concomitant second malignancies unless a complete remission was achieved at least 2 years before study entry\n* Have a history of Grade ≥ 2 pneumonitis, active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade ≥ 2\n* Have toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.\n* Have uncontrolled or significant cardiovascular disease\n* Part 1: major surgery within 3 weeks before initiating treatment\n* Part 1: Have received prior radiotherapy within 2 weeks of start of study treatment\n* Part 2 (H\\&N cancer):\n* Have received prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).\n* Have received prior chemotherapy administered in the recurrent advanced or metastatic setting (except for systemic therapy completed \\> 6 months prior to screening if given as part of multimodal treatment for locally advanced disease)'}, 'identificationModule': {'nctId': 'NCT05060432', 'acronym': 'TIG-006', 'briefTitle': 'Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'iTeos Therapeutics'}, 'officialTitle': 'A Multicenter, Open-Label, Phase I/II Study of EOS884448 (EOS-448) in Combination With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'TIG-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A - EOS-448 + pembrolizumab', 'description': 'Participants will receive EOS-448 and pembrolizumab at every cycle', 'interventionNames': ['Drug: EOS-448', 'Drug: pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B - EOS-448 + inupadenant', 'description': 'Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis', 'interventionNames': ['Drug: EOS-448', 'Drug: inupadenant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1C - EOS-448 + inupadenant', 'description': 'Participants will receive EOS-448 at every cycle and inupadenant on an ongoing basis', 'interventionNames': ['Drug: EOS-448', 'Drug: inupadenant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1D - EOS-448 + dostarlimab', 'description': 'Participants will receive EOS-448 and dostarlimab at every cycle', 'interventionNames': ['Drug: EOS-448', 'Drug: Dostarlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1E - inupadenant HCl + dostarlimab', 'description': 'Participants will receive dostarlimab at every cycle and inupadenant on an ongoing basis', 'interventionNames': ['Drug: inupadenant', 'Drug: Dostarlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1F - EOS-448 + dostarlimab + inupadenant HC', 'description': 'Participants will receive EOS-448 and dostarlimab at every cycle and inupadenant on an ongoing basis', 'interventionNames': ['Drug: EOS-448', 'Drug: inupadenant', 'Drug: Dostarlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1G - EOS-448 + dostarlimab + chemotherapies', 'description': 'Participants with 1L mNSCLC will receive EOS-448 and dostarlimab and chemotherapies at every cycle', 'interventionNames': ['Drug: EOS-448', 'Drug: Dostarlimab', 'Drug: SOC chemotherapies']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2C - EOS-448 + dostarlimab', 'description': 'Participants with 1L mHNSCC CPS ≥ 20 will receive EOS-448 and dostarlimab at every cycle', 'interventionNames': ['Drug: EOS-448', 'Drug: Dostarlimab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2D - EOS-448 + dostarlimab', 'description': 'Participants with 1L mHNSCC 1 \\< CPS \\< 20 will receive EOS-448 and dostarlimab at every cycle', 'interventionNames': ['Drug: EOS-448', 'Drug: Dostarlimab']}], 'interventions': [{'name': 'EOS-448', 'type': 'DRUG', 'otherNames': ['EOS884448', 'GSK4428859', 'belrestotug'], 'description': 'Anti-TIGIT monoclonal antibody', 'armGroupLabels': ['Part 1A - EOS-448 + pembrolizumab', 'Part 1B - EOS-448 + inupadenant', 'Part 1C - EOS-448 + inupadenant', 'Part 1D - EOS-448 + dostarlimab', 'Part 1F - EOS-448 + dostarlimab + inupadenant HC', 'Part 1G - EOS-448 + dostarlimab + chemotherapies', 'Part 2C - EOS-448 + dostarlimab', 'Part 2D - EOS-448 + dostarlimab']}, {'name': 'pembrolizumab', 'type': 'DRUG', 'description': 'Anti-PD-1 monoclonal antibody', 'armGroupLabels': ['Part 1A - EOS-448 + pembrolizumab']}, {'name': 'inupadenant', 'type': 'DRUG', 'otherNames': ['EOS100850'], 'description': 'A2A receptor antagonist', 'armGroupLabels': ['Part 1B - EOS-448 + inupadenant', 'Part 1C - EOS-448 + inupadenant', 'Part 1E - inupadenant HCl + dostarlimab', 'Part 1F - EOS-448 + dostarlimab + inupadenant HC']}, {'name': 'Dostarlimab', 'type': 'DRUG', 'description': 'Anti-PD-1 monoclonal antibody', 'armGroupLabels': ['Part 1D - EOS-448 + dostarlimab', 'Part 1E - inupadenant HCl + dostarlimab', 'Part 1F - EOS-448 + dostarlimab + inupadenant HC', 'Part 1G - EOS-448 + dostarlimab + chemotherapies', 'Part 2C - EOS-448 + dostarlimab', 'Part 2D - EOS-448 + dostarlimab']}, {'name': 'SOC chemotherapies', 'type': 'DRUG', 'description': 'SOC chemotherapies in 1L mNSCLC', 'armGroupLabels': ['Part 1G - EOS-448 + dostarlimab + chemotherapies']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '07601', 'city': 'Bergen', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.72927, 'lon': -74.0657}}, {'zip': '2610', 'city': 'Antwerp', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'GZA Ziekenhuizen campus Sint-Augustinus', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques universitaires St Luc-UCL', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'CHU Helora', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '33075', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Centre Georges Francois Leclerc', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '72000', 'city': 'Le Mans', 'country': 'France', 'facility': 'Clinique Victor Hugo', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Léon Bérard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '54519', 'city': 'Nancy', 'country': 'France', 'facility': 'Institut de Cancerologie Lorraine (ICL)', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44805', 'city': 'Nantes', 'country': 'France', 'facility': "Institut de Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de POITIERS', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '67033', 'city': 'Strasbourg', 'country': 'France', 'facility': 'ICANS', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'IDB Center-Istituto Clinico Humanitas (IRCCS)', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '10060', 'city': 'Candiolo', 'state': 'Turin', 'country': 'Italy', 'facility': 'FPO-IRCCS Candiolo Cancer Insitute', 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Universita degli Studi di Pavia - Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '48121', 'city': 'Ravenna', 'country': 'Italy', 'facility': 'AUSL Della Romagna - Ospedale S. Maria delle Croci', 'geoPoint': {'lat': 44.41344, 'lon': 12.20121}}, {'zip': '08243', 'city': 'Manresa', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital Althaia Xarxa Assitencial de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'zip': '06006', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Universitario de Badajoz', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '23007', 'city': 'Jaén', 'country': 'Spain', 'facility': 'Hospital Universitario de Jaen', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jiménez Díaz - START Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29004', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Quirón Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Hospital Universitario de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '41009', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Fundacion Instituto Valenciano de Oncologia (IVO)', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46014', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Consorci Hospital Gral Univ Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Universitario Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital (Sutton location)', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital (London location)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Iteos Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'iTeos Belgium SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iTeos Belgium SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'iTeos Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}