Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-08 @ 12:00 AM
Study NCT ID:
NCT03680560
Status:
TERMINATED
Last Update Posted:
2020-03-31
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D003528', 'term': 'Carcinoma, Adenoid Cystic'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Business Reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of ACTR T cell product with trastuzumab as assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of adverse events (AEs) and clinically significant abnormalities of laboratory values', 'timeFrame': '42 days'}, {'measure': 'Determination of recommended phase 2 dose (RP2D) regimen', 'timeFrame': '42 days', 'description': 'Review of DLTs, maximum tolerated dose (MTD), incidence and severity of AEs and clinically significant abnormalities of laboratory values'}], 'secondaryOutcomes': [{'measure': 'Anti-tumor activity as measured by overall response rate (ORR) per iRECIST', 'timeFrame': '52 weeks'}, {'measure': 'Anti-tumor activity as measured best overall response (BOR)', 'timeFrame': '52 weeks'}, {'measure': 'Anti-tumor activity as measured by duration of response (DOR)', 'timeFrame': '52 weeks'}, {'measure': 'Anti-tumor activity as measured by progression-free survival (PFS)', 'timeFrame': '52 weeks'}, {'measure': 'Anti-tumor activity as measured by overall survival (OS)', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of persistence of ACTR as measured by flow cytometry', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of persistence of ACTR as measured by quantitative polymerase chain reaction (qPCR)', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of ACTR phenotype and function as measured by flow cytometry', 'timeFrame': '52 weeks'}, {'measure': 'Assessment of induction of inflammatory markers and cytokines/chemokines after ACTR T cell product administration', 'timeFrame': '52 weeks', 'description': 'Levels of inflammatory markers, cytokines/chemokines in blood'}, {'measure': 'Trastuzumab pharmacokinetics (PK)', 'timeFrame': '52 weeks', 'description': 'trastuzumab serum concentration, Area Under the Curve (AUC), trough levels'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2', 'ACTR', 'ACTR087', 'ACTR707', 'T cell', 'T cell product', 'adoptive T cells', 'gene therapy', 'breast cancer', 'gastric cancer', 'gastro esophageal cancer', 'immunotherapy', 'solid tumor', 'adenoid cystic carcinoma'], 'conditions': ['Solid Tumor', 'HER-2 Protein Overexpression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.unumrx.com/', 'label': 'Sponsor Website'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, multi-center study to assess safety and determine the recommended phase 2 dose (RP2D) of ACTR T cell product (ACTR707 or ACTR087) in combination with trastuzumab, following lymphodepleting chemotherapy in subjects with HER2-positive advanced malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent obtained prior to study procedures\n* Histologically-confirmed Her2 positive advanced solid tumor malignancy with documented disease progression during or immediately following the immediate prior therapy, or within 6 months of completing adjuvant therapy for subjects with breast cancer\n* Subjects must have previously received adequate standard therapy for treatment of their malignancy\n\n * For those with metastatic breast cancer, must have received HER2-directed therapy including trastuzumab, pertuzumab and ado-trastuzumab in any breast cancer disease setting\n * For those with advanced gastric cancer, adequate prior treatment with HER2-directed chemotherapy is required\n* At least 1 measurable lesion by iRECIST\n* Able to provide fresh tumor biopsy or archived block specimen taken since time of most recent anti-HER2 mAb-directed therapy\n* ECOG of 0 or 1\n* Life expectancy ≥ 6 months\n* LVEF ≥ 50% by MUGA or ECHO\n* Absolute neutrophil (ANC) count ≥ 1500/ µL\n* Platelet count ≥ 100,000/µL\n* Hemoglobin ≥ 9g/dL\n* Estimated GFR \\>30mL/min/1.73m2\n\nExclusion Criteria:\n\n* glioblastoma multiforme or other primary CNS tumors are excluded\n* clinically significant cardiac disease\n* clinically significant active infection\n* clinical history, prior diagnosis, or overt evidence of autoimmune disease\n* current use of more than 5mg/day of prednisone (or an equivalent glucocorticoid)\n* Prior treatment as follows:\n\n * prior cumulative doxorubicin dose greater than or equal to 300 mg/m\\^2 or equivalent\n * chemotherapy within 2 weeks of enrollment\n * external beam radiation within 2 weeks of enrollment (28 days if CNS-directed therapy)\n * any monoclonal antibody (mAb) or other protein therapeutic containing Fc-domains within 4 weeks of enrollment\n * pertuzumab within 4 months of enrollment\n * Experimental agents within 3 half-lives or 28 days prior to enrollment, whichever is shorter\n * allogeneic hematopoietic stem cell transplant (HSCT)\n * prior infusion of a genetically modified therapy\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT03680560', 'briefTitle': 'Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cogent Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Study of an Autologous ACTR T Cell Product in Combination With Trastuzumab, a Monoclonal Antibody, in Subjects With HER2-Positive Advanced Malignancies', 'orgStudyIdInfo': {'id': 'ATTCK-34-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACTR T cell product in combination with trastuzumab', 'interventionNames': ['Biological: ACTR T Cell Product', 'Drug: Trastuzumab']}], 'interventions': [{'name': 'ACTR T Cell Product', 'type': 'BIOLOGICAL', 'description': 'Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)', 'armGroupLabels': ['ACTR T cell product in combination with trastuzumab']}, {'name': 'Trastuzumab', 'type': 'DRUG', 'description': 'monoclonal antibody targeting HER2', 'armGroupLabels': ['ACTR T cell product in combination with trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Smilow Cancer Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami University Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute/Tennessee Oncology, PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75201', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Glen Weiss, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cogent Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cogent Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}