Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-30 @ 12:44 PM
Study NCT ID:
NCT05069935
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2021-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], '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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}, {'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': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'This study was terminated by the Sponsor.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2021-09-10', 'studyFirstSubmitQcDate': '2021-10-01', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define the Recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Up to ~1.5 years', 'description': 'To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab'}, {'measure': 'Incidence and Severity of Adverse Events (AEs)0', 'timeFrame': 'Up to ~5 years', 'description': 'To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-PD-1 / PD-L1 antibodies approved', 'HER2+', 'Metastatic CRC', 'Head and Neck Squamous Cell Carcinoma', 'NK Cells', 'Urothelial Cancer', 'Renal Cell Carcinoma', 'merkel cell carcinoma', 'non-small cell lung cancer', 'NSCLC', 'triple negative breast cancer', 'immune checkpoint inhibitor', 'melanoma, renal cell carcinoma, lung cancer,', 'triple-negative breast cancer,', 'head and neck squamous cell carcinoma,', 'urothelial carcinoma (UC),', 'Merkel cell carcinoma, squamous', 'hepatocellular carcinoma', 'gastric cancer, esophageal cancer, endometrial cancer,'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.', 'detailedDescription': 'This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:\n\n* Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase\\], cutaneous squamous cell carcinoma, triple-negative breast cancer.\n* Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.\n* Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.\n\nCapable of giving signed informed consent\n\nAged \\~ 18 years old\n\nWillingness to comply with study procedures and duration\n\nMeasurable disease per RECIST v1.1\n\nFor subjects with \\>1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy\n\nContraceptive use for women and men as defined in the protocol\n\nExclusion Criteria:\n\nPregnant or breast-feeding women\n\nECOG performance status greater than or equal to 2\n\nEvidence of insufficient organ function\n\nClinically significant cardiovascular disease including left-ventricular ejection fraction \\< 45%\n\nReceipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1\n\nKnown active central nervous system (CNS) involvement by malignancy that hasn'thas not remained stable for at least 3 months following effective treatment for CNS disease\n\nNon-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions\n\nCurrently receiving or likely to require immunosuppressive therapy Active bacterial, fungal, or viral infections including hep B, Hep C or HIV Live vaccine within 6 weeks prior to start of lympho-conditioning\n\nKnown allergy to albumin (human) or DMSO"}, 'identificationModule': {'nctId': 'NCT05069935', 'briefTitle': 'FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fate Therapeutics'}, 'officialTitle': 'A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'FT538-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': '* Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved\n* Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors\n* Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)', 'interventionNames': ['Drug: FT538', 'Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Combination Product: Monoclonal antibody - Dose Escalation']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': '* Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))\n* Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)\n* Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors\n* Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC\n\nSubjects with UC may be enrolled in the randomized expansion cohorts as follows:\n\n* Cohort A, Arm R1: FT538 plus avelumab\n* Cohort A, Arm R2: FT538 plus atezolizumab', 'interventionNames': ['Drug: FT538', 'Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Combination Product: Monoclonal antibody - Dose Expansion']}], 'interventions': [{'name': 'FT538', 'type': 'DRUG', 'otherNames': ['NK Cell Therapy'], 'description': 'FT538 is an allogeneic natural killer (NK)-cell immunotherapy', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cy'], 'description': 'Lympho-conditioning agent', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}, {'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['Flu'], 'description': 'Lympho-conditioning agent', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}, {'name': 'Monoclonal antibody - Dose Escalation', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['mAb'], 'description': 'either avelumab, trastuzumab or cetuximab', 'armGroupLabels': ['Dose Escalation']}, {'name': 'Monoclonal antibody - Dose Expansion', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['mAb'], 'description': 'either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab', 'armGroupLabels': ['Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Fate Trial Disclosure', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fate Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fate Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}