Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT05843305
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BPI-452080 in Subjects With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D006623', 'term': 'von Hippel-Lindau Disease'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000798', 'term': 'Angiomatosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'Maximum observed concentration'}, {'measure': 'Tmax', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'Time to reach maximum observed plasma concentration'}, {'measure': 't1/2', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'Half-life time'}, {'measure': 'the objective response rate（ORR）', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'The proportion of patients with complete response (CR) and partial response (PR) in all patients'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'Through the Phase I, approximately 24 months', 'description': 'The time from the date of randomization to disease progression (PD) or death, whichever occurs first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor', 'Renal Cell Carcinoma', 'Von Hippel-Lindau Disease']}, 'descriptionModule': {'briefSummary': 'This open-label Phase 1 study will evaluate the efficacy and safety of BPI-452080 in patients with Solid Tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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:\n\nArm1：has locally advanced or metastatic ccRCC and has progressed during treatment with at least one prior therapeutic regimen Arm2：Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma Arm3：Other solid tumors\n\n* Adequate organ function\n* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion required for dose expansion phase\n\nExclusion Criteria:\n\n* Has received prior treatment with another HIF-2α 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, moderate or strong CYP3A inhibitor or inducer, etc\n* Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05843305', 'briefTitle': 'A Study of BPI-452080 in Subjects With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Betta Pharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-452080 in Subjects With Solid Tumors', 'orgStudyIdInfo': {'id': 'BTP-661811'}}, '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-452080 administered once daily.', 'interventionNames': ['Drug: BPI-452080']}, {'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-452080 administered once daily.\n\nCohort 1: Locally Advanced or Metastatic ccRCC Cohort 2: VHL disease associated RCC Cohort 3: Other Advanced Solid Tumors', 'interventionNames': ['Drug: BPI-452080']}], 'interventions': [{'name': 'BPI-452080', 'type': 'DRUG', 'description': 'Subjects will receive BPI-452080 until disease progression', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201321', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Dingwei Ye, Ph.D', 'role': 'CONTACT', 'email': 'fuscc2012@163.com', 'phone': '13701663571'}, {'name': 'Jian Zhang, Ph.D', 'role': 'CONTACT', 'email': 'Syner2000@163.com', 'phone': '13918273761'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'contacts': [{'name': 'Zhenhua Liu', 'role': 'CONTACT'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310000', 'city': 'Hangzhou', 'country': 'China', 'contacts': [{'name': 'Meiyu Fang', 'role': 'CONTACT'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '410031', 'city': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Shusuan Jiang', 'role': 'CONTACT'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'zip': '430000', 'city': 'Wuhan', 'country': 'China', 'contacts': [{'name': 'Xiaoping Zhang', 'role': 'CONTACT'}], 'facility': 'Union Hospital Tongji Medical College Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Dingwei Ye, Ph.D', 'role': 'CONTACT', 'email': 'fuscc2012@163.com', 'phone': '13701663571'}, {'name': 'Jian Zhang, Ph.D', 'role': 'CONTACT', 'email': 'Syner2000@163.com', 'phone': '13918273761'}], 'overallOfficials': [{'name': 'Dingwei Ye, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}, {'name': 'Jian Zhang, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Betta Pharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}