Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-02 @ 1:48 PM
Study NCT ID:
NCT06547957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711728', 'term': 'spartalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-08-07', 'lastUpdatePostDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the safety and tolerability of EOS301984 alone and in combination with other anticancer agents in participants with advanced solid tumors', 'timeFrame': 'From first study treatment administration to last participant last follow-up (Up to 4 years)'}, {'measure': 'Incidence and severity of AEs in patients receiving EEOS301984', 'timeFrame': 'From first study treatment administration to last participant last follow-up (Up to 4 years)'}], 'secondaryOutcomes': [{'measure': 'Mean and median Area under the curve (AUC) of EOS301984 following first dose and repeated administration at each dose level', 'timeFrame': 'From first dose up to 21 days repeated cycles'}, {'measure': 'Mean and median Maximum concentration (Cmax) of EOS301984 following first dose and repeated administration at each dose level', 'timeFrame': 'From first dose up to 21 days repeated cycles'}, {'measure': 'Define the recommended Phase 2 dose (RP2D) in participants with advanced tumors.', 'timeFrame': 'From first study treatment administration to last participant last follow-up (Up to 4 years)'}, {'measure': 'Percentage of participants with Objective Response as determined by Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1', 'timeFrame': 'From first study treatment administration to last participant last follow-up (Up to 4 years)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced solid tumors', 'neoplasm', 'cancer', 'phase I', 'immunotherapy', 'anticancer'], 'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'APT-008 is an open-label, Phase I/Ib, dose escalation and expansion cohort study to evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamic (PD), and preliminary efficacy of EOS301984 as monotherapy and in combination with other anticancer therapies in participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Provide a signed written informed consent before any study-specific evaluation.\n* Be at least 18 years old on the day of signing informed consent.\n* Have a histologically confirmed advanced solid tumor for which no standard approved treatment is available, or are ineligible for, or did not tolerate standard approved treatment.\n* Have at least one tumor lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Have adequate organ and marrow function.\n* Agree to use adequate highly effective method of contraception during the study is mandatory, if Women of Childbearing Potential (WOCBP) or male.\n\nEXCLUSION CRITERIA\n\n* Have received prior systemic anticancer treatment including investigational agents within 4 weeks before the first dose of study treatment.\n* Have major surgery planned or have had a major surgery within 5 weeks before the first dose of the study treatment.\n* Have received prior radiotherapy within 2 weeks before the first dose of study treatment.\n* Have allergy to study treatment(s) or any of its components.\n* Have a history or current evidence of uncontrolled or significant cardiovascular disease. Unable to comply with the requirements of the study or who, in the opinion of the Investigator, should not participate in the study.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT06547957', 'briefTitle': 'A First-in-Human Study of EOS301984 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'iTeos Therapeutics'}, 'officialTitle': 'A First-in-Human Open-label, Phase I Dose Escalation and Expansion Cohort Study of EOS301984 as Monotherapy and in Combination With Other,Anticancer Treatments in Participants With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'APT-008'}, 'secondaryIdInfos': [{'id': '2023-503844-14-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A dose escalation', 'description': 'EOS301984 dose escalation as monotherapy', 'interventionNames': ['Drug: EOS301984']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B dose escalation', 'description': 'EOS301984 in combination with other cancer therapies', 'interventionNames': ['Drug: EOS301984', 'Drug: Anti-PD-1 monoclonal antibody']}], 'interventions': [{'name': 'EOS301984', 'type': 'DRUG', 'otherNames': ['EOS-984'], 'description': 'Multiple doses of EOS301984', 'armGroupLabels': ['Part 1A dose escalation', 'Part 1B dose escalation']}, {'name': 'Anti-PD-1 monoclonal antibody', 'type': 'DRUG', 'description': 'Multiple doses of EOS301984 in combination with Anti-PD-1', 'armGroupLabels': ['Part 1B dose escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6060', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'GZA Ziekenhuizen campus Sint-Augustinus', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}], 'overallOfficials': [{'name': 'Iteos Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'iTeos Therapeutics Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iTeos Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}