Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT03544905
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634149', 'term': 'CYH33'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 206}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD(Max tolerance does)', 'timeFrame': '35 days', 'description': 'To evaluate the MTD in patients with advanced solid tumor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is a Multi-center, Open-label, single arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety , Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.', 'detailedDescription': 'This study includes Phase Ia and Phase Ib.\n\nIn the dose climbing part of phase Ia, the safety, tolerance and pharmacokinetics characteristics of CYH33 in patients with advanced solid tumors who failed to receive standard treatment, did not tolerate or did not have standard treatment at present will be observed to determine MTD; Before determining MTD, select safe and highly reliable and effective dose levels for simultaneous expansion. Phase Ia dose expansion includes patients with advanced solid tumors who have failed to undergo standard treatment, who are intolerant of PIK3CA gene mutation, or who do not have standard treatment at present, to further evaluate safety, tolerance and initial efficacy.\n\nIn Phase Ib, the safety and preliminary efficacy of CYH33 on patients with advanced breast cancer, ovarian cancer, endometrial cancer, cervical cancer, head and neck squamous cell carcinoma, esophageal and gastroesophageal junction squamous cell carcinoma, ovarian clear cell carcinoma and other solid tumors with PIK3CA gene mutation who have failed, are intolerant or do not have standard treatment at present will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* main inclusion:\n\n 1. Evidence of a personally signed informed consent document;\n 2. Male and/or female subjects above the ages of 18 years;\n 3. Locally advanced or metastatic solid tumor patients who have failed or relapsed on current standard of care for Phase 1a;\n 4. Subject may provide Tumor tissue section(at least 8 pieces) if they agree;\n 5. ECOG performance score 0-1;\n 6. Life expectancy ≥ 12 weeks;\n 7. At least 1 measurable target lesion on the baseline scan as per RECIST 1.1\n\nExclusion Criteria:\n\n* main criteria:\n\n 1. prior received anti-tumor treatment, including anticancer drugs for the treatment within 28 days of first dose of study treatment;\n 2. Prior or concomitant other malignant tumor;'}, 'identificationModule': {'nctId': 'NCT03544905', 'briefTitle': 'Study to Evaluate the Safety, Tolerate, Pharmacokinetics and Preliminary Efficacy of CYH33', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haihe Biopharma Co., Ltd.'}, 'officialTitle': 'A Multi-center, Open-label, Single Arm, Dose Escalation and Dose Extension Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Advanced Solid Tumors Patients.', 'orgStudyIdInfo': {'id': 'CYH33-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose escalation study of CYH33', 'description': 'To determine the maximum tolerated dose (MTD) of CYH33', 'interventionNames': ['Drug: CYH33 for tablet']}], 'interventions': [{'name': 'CYH33 for tablet', 'type': 'DRUG', 'description': '1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)', 'armGroupLabels': ['Dose escalation study of CYH33']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '237005', 'city': "Lu'an", 'state': 'Anhui', 'country': 'China', 'facility': "Lu'an People's Hospital", 'geoPoint': {'lat': 31.73561, 'lon': 116.51688}}, {'zip': '237006', 'city': "Lu'an", 'state': 'Anhui', 'country': 'China', 'facility': "Lu'an Hospital of Traditional Chinese Medicine", 'geoPoint': {'lat': 31.73561, 'lon': 116.51688}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '361101', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': "Xiang'an Hospital of Xiamen University", 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '523000', 'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan People's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510220', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen Memorial Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '512026', 'city': 'Shaoguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Yuebei People's Hospital", 'geoPoint': {'lat': 24.8, 'lon': 113.58333}}, {'zip': '518116', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shenzhen Hospital of Cancer Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '545005', 'city': 'Liuchow', 'state': 'Guangxi', 'country': 'China', 'facility': 'Liuzhou Workers Hospital', 'geoPoint': {'lat': 24.32405, 'lon': 109.40698}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Affiliated Tumor Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '455000', 'city': 'Anyang', 'state': 'Henan', 'country': 'China', 'facility': 'Anyang Cancer Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'zip': '473000', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'facility': "Nanyang First People's Hospital", 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'zip': '473000', 'city': 'Nanyang', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Nanyang Medical College', 'geoPoint': {'lat': 32.99472, 'lon': 112.53278}}, {'zip': '450008', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430071', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '412002', 'city': 'Zhuzhou', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Province Directly Affiliated Traditional Chinese Medicine Hospital', 'geoPoint': {'lat': 27.83333, 'lon': 113.15}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Liaoning Cancer Hospital', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200090', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Obstetrics and Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '671000', 'city': 'Dali', 'state': 'Yunnan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dali University', 'geoPoint': {'lat': 25.58474, 'lon': 100.21229}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Ruihua Xu, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haihe Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}