Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT05789602
Status:
RECRUITING
Last Update Posted:
2025-01-27
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BPI-460372 in Advanced Solid Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-04-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The adverse events (AEs)', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).'}, {'measure': 'The dose-limiting toxicity（DLT）', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'The dose-limiting toxicity'}, {'measure': 'Determine the Maximum Tolerated Dose (MTD)', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'The MTD will be based on DLT.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the pharmacokinetics of BPI-460372', 'timeFrame': 'Time Frame: Through the Phase I, approximately 24 months', 'description': 'Based on blood plasma concentration'}, {'measure': 'Evaluate the effectiveness of BPI-460372', 'timeFrame': 'Time Frame: Through the Phase I, approximately 24 months', 'description': 'Efficacy assessments (tumor evaluation) will be performed per RECIST1.1 or mRECIST1.1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, single arm, dose escalation and dose expansion phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BPI-460372 in solid tumor patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent;\n* Age ≥18, male and female patients；\n* Expected survival ≥ 3 months；\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;\n* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Dose expansion phase: histologically or cytologically confirmed locally advanced Malignant mesothelioma, Epithelioid hemangioendothelioma or other diagnosed solid tumor patients with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, and other Hippo signaling pathway abnormalities , who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;\n* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 or mRECIST v1.1 required for dose expansion phase;\n\nExclusion Criteria:\n\n* Patients who have previously received a TEAD inhibitor;\n* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation，etc；\n* Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, meningeal metastasis and spinal cord compression，malignant tumors, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;\n* Pregnancy or lactation;\n* Other conditions considered not appropriate to participate in this trial by the investigators.'}, 'identificationModule': {'nctId': 'NCT05789602', 'briefTitle': 'A Study of BPI-460372 in Advanced Solid Tumor Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BPI-460372 in Advanced Solid Tumor Patients', 'orgStudyIdInfo': {'id': 'BTP-661911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'Oral tablets taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD).', 'interventionNames': ['Drug: BPI-460372']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion', 'description': 'Oral tablets administered at MTD/RP2D defined dose. Each treatment cycle will be 21 days in duration with BPI-460372 administered, once daily (QD)', 'interventionNames': ['Drug: BPI-460372']}], 'interventions': [{'name': 'BPI-460372', 'type': 'DRUG', 'description': 'Subjects will receive BPI-460372 until disease progression', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mengzhao Wang', 'role': 'CONTACT', 'email': 'mengzhaowang@sina.com', 'phone': '010-69155039'}, {'name': 'Xiaohong Han', 'role': 'CONTACT', 'email': 'hanxiaohong@pumch.cn', 'phone': '010-69156114'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yutao Liu', 'role': 'CONTACT'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '050031', 'city': 'Baoding', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aimin Zang', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Hebei University', 'geoPoint': {'lat': 38.87288, 'lon': 115.46246}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Yu', 'role': 'CONTACT'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Chu', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital Tongji Medical College of HUST', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410031', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Wu', 'role': 'CONTACT'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '130033', 'city': 'Changchun', 'state': 'Jilin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Linlin Liu', 'role': 'CONTACT'}], 'facility': 'China-Japan Union Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meili Sun', 'role': 'CONTACT'}, {'name': 'Qing Wen', 'role': 'CONTACT'}], 'facility': 'Central Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ligang Xing', 'role': 'CONTACT'}], 'facility': 'Shandong Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '317000', 'city': 'Taizhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongqing Lv', 'role': 'CONTACT'}], 'facility': 'Taizhou Hospital of Zhejiang Province', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Zhengzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingya Li', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Mengzhao Wang, Ph.D', 'role': 'CONTACT', 'email': 'mengzhaowang@sina.com', 'phone': '010-69155039'}, {'name': 'Xiaohong Han, Ph.D', 'role': 'CONTACT', 'email': 'hanxiaohong@pumch.cn', 'phone': '010-69156114'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}