Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT04648202
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2020-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FS120 Phase 1/1b Study in Patients With Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence, severity, and duration of adverse events (AEs), serious adverse events (SAEs) and dose limiting toxicities (DLTs)', 'timeFrame': '24 months', 'description': 'Safety and tolerability will be evaluated by collection of AEs, SAEs and DLTs according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.'}, {'measure': 'Determination of a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)', 'timeFrame': '24 months', 'description': 'Toxicity will be evaluated according to the NCI CTCAE Version 5.0.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immuno-oncology', 'Bispecific antibody', 'Dose escalation', 'Cohort expansion', 'OX40', 'CD137 (4-1BB)', 'invoX', 'Pembrolizumab', 'PD-1'], 'conditions': ['Advanced Cancer', 'Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1/1b, multicenter, open label study to evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination with Pembrolizumab, in Subjects with Advanced Malignancies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Measurable disease\n* Eastern Cooperative Oncology Group Performance Status 0-1.\n* Highly effective contraception if risk of conception exists\n* A female subject is eligible if not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) or is a WOCBP that uses highly effective contraception\n* Subjects with HIV who are healthy and how a low risk of acquired immunodeficiency syndrome related outcomes\n* For combination part: Subjects must have histologically confirmed locally advanced, unresectable or metastatic solid tumours where there is regulatory approval for use of pembrolizumab as a monotherapy agent\n\nExclusion Criteria:\n\n* Prior systemic anticancer therapy within 28 days or 5- half-lives, whichever is shorter, before the first dose of study drug.\n* Prior therapy with any OX40 agonist, CD137 (4-1BB) agonist, CD40 agonist, GITR, or CD27 targeting therapy (single agent or combination).\n* Prior radiotherapy within 2 weeks of start of study treatment.\n* HIV infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.\n* Uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis, primary CNS tumours, or solid tumours with CNS metastases as the only measurable disease.\n* Prior history of any grade ≥3 immune-related AE (irAE) that has not improved to grade ≤1; any grade ≥3 irAE that resulted in discontinuation of treatment, significant (grade ≥3 NCI CTCAE Version 5.0) treatment-related cytokine release syndrome.\n* Use of immunosuppressive agents, hypersensitivity or intolerance to monoclonal antibodies or their excipients, persistent grade ≥1 NCI CTCAE Version 5 toxicity related to prior therapy or any condition that would significantly impair and/or prohibit the participant's participation in the study, as per the investigator's judgement.\n* Vaccination with a live vaccine within 30 days before first dose of study drug.\n* Participants with a known additional malignancy that is progressing or has required active treatment in the past 3 years.\n* Participants with severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients."}, 'identificationModule': {'nctId': 'NCT04648202', 'briefTitle': 'FS120 Phase 1/1b Study in Patients With Advanced Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'invoX Pharma Limited'}, 'officialTitle': 'A Phase 1/1b Open-Label Study to Evaluate the Safety and Antitumor Activity of FS120, an OX40/CD137 Bispecific Antibody, Alone and in Combination With Pembrolizumab, in Subjects With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'FS120-19101'}, 'secondaryIdInfos': [{'id': '2021-002820-19', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-3475-C82', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}, {'id': 'KEYNOTE-C82', 'type': 'OTHER', 'domain': 'Merck Sharp & Dohme LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FS120', 'description': 'Open-label study where FS120 will be administered as monotherapy or in combination with pembrolizumab in dose escalation and expansion cohorts', 'interventionNames': ['Drug: FS120']}], 'interventions': [{'name': 'FS120', 'type': 'DRUG', 'otherNames': ['Pembrolizumab (KEYTRUDA®)'], 'description': 'Dosing of participants with FS120 or the combination pembrolizumab will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) or once every 3 weeks (Q3W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.', 'armGroupLabels': ['FS120']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'South Texas Accelerated Research Therapeutics (START)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute, University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '08023', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'NEXT Oncology, Hospital Quironsalud Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundacion Jimenez Diaz', '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': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'invoX Pharma Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}