Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT05673694
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2022-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2022-12-30', 'studyFirstSubmitQcDate': '2022-12-30', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of EG017 as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs).', 'timeFrame': '28 Days', 'description': 'The CTCAE criteria will be used to assess adverse events on this trial.'}, {'measure': 'The effectiveness of EG017 in humans was evaluated by clinical benefit rate', 'timeFrame': '24 Weeks', 'description': 'The number and proportion of subjects in clinical remission at 24 weeks after administration were calculated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, tolerability, pharmacokinetics and efficacy of EG017 in androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor receptor-2-negative patients with advanced breast cancer.', 'detailedDescription': 'The major aims of the study are to define the safety profile of this new drug, and to determine a recommended.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'postmenopausal women or women in a postmenopausal state', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female, 18-75 years old;\n2. Expected survival ≥ 12 weeks;\n3. Subjects with ECOG score of physical state 0\\~1;\n4. Histologically confirmed recurrent or metastatic advanced breast cancer;\n\nExclusion Criteria:\n\n1. Those who have had a severe allergic reaction to any drug or its components in this study in the past;\n2. Present with primary central nervous system (CNS) malignancies; Subjects with CNS metastasis who have failed local treatment (except asymptomatic BMS, or symptomatic BMS with complete remission of symptoms ≥ 2 weeks after treatment for BMS);\n3. Has any disease or syndrome that requires or is likely to require systemic steroid therapy during the study period;\n4. Gastrointestinal disorders or gastrointestinal diseases will significantly affect the absorption of test drugs (such as ulcerative disease, uncontrolled vomiting, diarrhea, malabsorption syndrome, biliary drainage status, etc.), or subjects cannot take drugs orally:'}, 'identificationModule': {'nctId': 'NCT05673694', 'briefTitle': 'To Evaluate a Phase Ia/Ib Clinical Study of EG017 in Patients With Advanced Breast Cancer.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of EG017 in Androgen Receptor-positive, Estrogen Receptor-positive, and Human Epidermal Growth Factor Receptor-2-negative Patients With Advanced Breast Cancer.', 'orgStudyIdInfo': {'id': 'EG017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EG017', 'description': '70 subjects: Part Ia 10 subjects: A total of 3 dose groups of 6 mg/day, 18 mg/day, 24 mg/day are planned. Once a day, each treatment cycle was administered for 28 days.\n\nPart Ib 60 subjects: A total of 2 dose groups of 18 mg/day, 24 or 12mg/day are planned. Once a day, each treatment cycle was administered for 28 days.', 'interventionNames': ['Drug: EG017']}], 'interventions': [{'name': 'EG017', 'type': 'DRUG', 'description': 'According to the dosage group of the program, once a day.', 'armGroupLabels': ['EG017']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Benjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binghe Xu, Doctor', 'role': 'CONTACT', 'email': 'xubinghe@medmail.com.cn', 'phone': '+86-10-87788826'}], 'facility': 'Cancer Hospital of CAMS', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Wei Wang', 'role': 'CONTACT', 'email': 'wangwei13@genscigroup.com', 'phone': '+86 18201085833'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}