Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-01-01 @ 8:24 PM
Study NCT ID:
NCT04319757
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2020-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2020-03-18', 'studyFirstSubmitQcDate': '2020-03-22', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tumor response using Response Evaluation Criteria In Solid Tumors Assessment (RECIST) version 1.1', 'timeFrame': 'Day 35 (+7 day window) of each 6 week cycle, up to 24 months', 'description': 'Tumor response via radiographic assessments'}, {'measure': 'Shift in serum tumor marker values (CA-125, CA 19-9, and CEA levels, in applicable tumor types)', 'timeFrame': 'Day 35 (+7 day window) of each 6 week cycle, up to 24 months', 'description': 'Tumor response via tumor marker assessments (in applicable tumor types)'}], 'primaryOutcomes': [{'measure': 'Adverse events, including Dose Limiting Toxicities (DLTs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 7 through Day 28 / Day 4 through Day 25', 'description': 'Number of subjects experiencing adverse events, and the frequency and severity of adverse events.\n\nEndpoint for determining the Maximum Tolerated Dose (MTD). If MTD is not identified, the highest dose administered becomes the Maximum Administered Dose (MAD).'}, {'measure': 'Phase Ib/II starting dose for ACE1702', 'timeFrame': 'Through study completion, up to 1 year', 'description': 'The recommended phase Ib/II starting dose based on MTD. If MTD is not reached, then the recommended phase Ib/II dose will be determined based on the MAD, safety data, and pharmacodynamics data.'}], 'secondaryOutcomes': [{'measure': 'Quantify NK cell persistence after administering ACE1702', 'timeFrame': 'Day 21', 'description': 'Duration of ACE1702 persistence'}, {'measure': 'Evaluate immune function after administering ACE1702', 'timeFrame': 'Day 21', 'description': 'Measurement of serum cytokine levels, pg/mL (Interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10) at set timepoints'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NK Cell Therapy', 'Cellular Therapy', 'Breast Cancer', 'Gastric Cancer', 'Ovarian Cancer', 'Endometrial Cancer', 'Metastatic Cancer', 'Colorectal Cancer', 'Head and Neck Cancer', 'Pancreatic Cancer', 'Bladder Cancer', 'Non-small-cell Lung Carcinoma'], 'conditions': ['Locally Advanced Solid Tumor', 'Metastatic Cancer', 'Solid Tumor', 'HER2-positive Gastric Cancer', 'HER2-positive Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'ACE1702 (anti-HER2 oNK cells) is an off-the-shelf Natural Killer (NK) cell product that targets human HER2-expressing solid tumors. The ACE1702-001 phase I study aims to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ACE1702 in patients with advanced or metastatic HER2-expressing tumors, and to determine the phase Ib/II starting dose for ACE1702.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Subjects must be ≥ 18 years of age ( ≥ 20 years of age for Taiwan site)\n* Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit.\n* Histologically confirmed HER2 expression.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1\n* Measurable or non-measurable evaluable disease according to RECIST 1.1\n* Adequate hematologic and end-organ function at baseline\n* Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air\n\nExclusion Criteria:\n\n* Untreated central nervous system (CNS) metastases\n* Multiple primary malignancies\n* Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater)\n* Pregnant or lactating female\n* Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment\n* History of autoimmune or immune mediated symptomatic disease\n* Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of the study'}, 'identificationModule': {'nctId': 'NCT04319757', 'briefTitle': 'ACE1702 in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acepodia Biotech, Inc.'}, 'officialTitle': 'A Phase I, Open Label, Dose Escalation Study of ACE1702 Cell Immunotherapy in Subjects With Advanced or Metastatic HER2-expressing Solid Tumors', 'orgStudyIdInfo': {'id': 'ACE1702-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACE1702 Dose Level 1', 'description': 'Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 immunohistochemistry (IHC) 2+ or above.\n\nDose Level: 1 Planned number of subjects: 1 to 6', 'interventionNames': ['Drug: ACE1702', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'ACE1702 Dose Level 2', 'description': 'Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.\n\nDose Level: 2 Planned number of subjects: 1 to 6', 'interventionNames': ['Drug: ACE1702', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'ACE1702 Dose Level 3', 'description': 'Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.\n\nDose Level: 3 Planned number of subjects: 3 to 6', 'interventionNames': ['Drug: ACE1702', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'ACE1702 Dose Level 4', 'description': 'Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.\n\nDose Level: 4 Planned number of subjects: 3 to 6', 'interventionNames': ['Drug: ACE1702', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'ACE1702 Dose Level 5', 'description': 'Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.\n\nDose Level: 5 Planned number of subjects: 3 to 6', 'interventionNames': ['Drug: ACE1702', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'EXPERIMENTAL', 'label': 'ACE1702 Dose 6', 'description': 'Lympho-conditioning agents followed by ACE1702 (anti-HER2 oNK cells) will be administered to patients with advanced or metastatic, HER2-expressing solid tumors. HER2 expressing is defined has having HER2 IHC 2+ or above.\n\nDose Level: 6 Planned number of subjects: 3 to 6', 'interventionNames': ['Drug: ACE1702', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}], 'interventions': [{'name': 'ACE1702', 'type': 'DRUG', 'description': 'ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously', 'armGroupLabels': ['ACE1702 Dose 6', 'ACE1702 Dose Level 1', 'ACE1702 Dose Level 2', 'ACE1702 Dose Level 3', 'ACE1702 Dose Level 4', 'ACE1702 Dose Level 5']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Lympho-conditioning agent', 'armGroupLabels': ['ACE1702 Dose 6', 'ACE1702 Dose Level 1', 'ACE1702 Dose Level 2', 'ACE1702 Dose Level 3', 'ACE1702 Dose Level 4', 'ACE1702 Dose Level 5']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Lympho-conditioning agent', 'armGroupLabels': ['ACE1702 Dose 6', 'ACE1702 Dose Level 1', 'ACE1702 Dose Level 2', 'ACE1702 Dose Level 3', 'ACE1702 Dose Level 4', 'ACE1702 Dose Level 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Univeristy', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veteran General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Michael Kurman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acepodia Biotech, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acepodia Biotech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}