Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT05245058
Status:
RECRUITING
Last Update Posted:
2025-08-17
First Post:
2022-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Up to 24 days', 'description': 'Measurement of DLT of SPH5030 in all subjects'}, {'measure': 'Maximum tolerated dose（MTD）', 'timeFrame': 'Up to 24 days', 'description': 'Measurement of MTD of SPH5030 in all subjects'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'Up to 2 years', 'description': 'Adverse event type, incidence, duration, correlation with study drug'}], 'secondaryOutcomes': [{'measure': 'Maximum serum concentration (Cmax) of SPH 5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Time of maximum serum concentration (Tmax) SPH 5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-14) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Terminal rate constant(λz) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Half-life (t1/2) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Total clearance(CL) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Volume of distribution(Vz) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Percentage of area under the serum concentration-time curve (AUC) obtained by extrapolation (%AUCex) of SPH5030', 'timeFrame': 'Up to 2 years', 'description': 'To characterize the PK (Pharmacokinetics) of SPH 5030'}, {'measure': 'Objective Response Rate (Investigator)', 'timeFrame': 'Up to 2 years', 'description': 'Determination of the Objective Response Rate of all patients by investigators'}, {'measure': 'Duration of remission (DOR)', 'timeFrame': 'Up to 2 years', 'description': 'Time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review as per RECIST v1.1.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to 2 years', 'description': 'The proportion of patients with best confirmed RECIST response of CR, PR, or duration of SD.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'The interval between the dates of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first.'}, {'measure': '6-month Progression-free Survival (6mPFS)', 'timeFrame': 'Up to 2 years', 'description': 'Number of Patients Achieving 6-month Progression-free Survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HER2-positive Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ECOG performance status of 0 to 1.\n2. Life expectancy of more than 3 months.\n3. At least one measurable lesion exists.(RECIST 1.1)\n4. Histologically or cytologic confirmed HER2 positive metastatic solid tumor which failed prior standard treatment or have no standard treatment.\n5. Required laboratory values including following parameters:\n\n ANC: ≥ 1.5 x 109/L Plt count: ≥ 90x 109/L Hb: ≥ 90 g/L TBIL: ≤ 1.5 x ULN, ALT and AST: ≤ 2.5 x ULN and creatine clearance rate: ULN or≥ 50 mL/min\n6. Toxicity from previous antitumor therapy returned to baseline (except for residual hair loss effects) or CTCAE≤ class 1.\n7. Blood pregnancy test was negative within 3 days prior to first dose.\n\nExclusion Criteria:\n\n1. Subjects who have received the prescribed treatment at the prescribed time prior to first dosing.\n2. Known active infection within 2 weeks prior to baseline.\n3. Subjects with third space fluid that can not be controled.\n4. Subjects with uncontrolled or severe cardiovascular disease.\n5. Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.\n6. Subjects with severe lung disease.\n7. Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.\n8. Using a potent CYP3A4 or CYP2C8 inhibitor or inducer.\n9. Steroid treatment for more than 50 days before, or in need of long-term use of steroids.\n10. Uncured other tumors within 5 years.\n11. Subjects with symptomatic CNS metastasis, pia meningeal metastasis, or spinal cord compression due to metastasis.\n12. Evidence of chronic active hepatitis B or C\n13. Uncontrolled systemic diseases, including hypertension that cannot be effectively controlled after treatment.\n14. Receive any live or attenuated live vaccine within 28 days prior to baseline.\n15. Evidence of severe allergies.\n16. Evidence of alcohol or drug abuse.\n17. Evidence of neurological or psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT05245058', 'briefTitle': 'SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Pharmaceuticals Holding Co., Ltd'}, 'officialTitle': 'A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of SPH5030 Tablets in Subjects With Advanced Her2-positive Solid Tumors', 'orgStudyIdInfo': {'id': 'SPH5030-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPH5030 tablets', 'description': 'Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day.\n\nEach subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.', 'interventionNames': ['Drug: SPH5030 tablets']}], 'interventions': [{'name': 'SPH5030 tablets', 'type': 'DRUG', 'description': 'SPH5030 tablets orally once or twice daily.', 'armGroupLabels': ['SPH5030 tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yueyin Pan', 'role': 'CONTACT'}], 'facility': 'Anhui provincial hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Binghe Xu', 'role': 'CONTACT'}, {'name': 'Binghe Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunxing Song', 'role': 'CONTACT', 'email': 'songyx@sphchina.com', 'phone': '+86 17813230827'}, {'name': 'Yanxia Shi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weimin Xie', 'role': 'CONTACT'}], 'facility': 'Guangxi Cancer Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cuizhi Geng', 'role': 'CONTACT'}], 'facility': 'The Fourth Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingyuan Zhang', 'role': 'CONTACT'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'city': 'Anyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Sun', 'role': 'CONTACT'}], 'facility': 'Anyang Cancer Hospital', 'geoPoint': {'lat': 36.096, 'lon': 114.38278}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan', 'role': 'CONTACT'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Xiangyang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuehua Wang', 'role': 'CONTACT'}], 'facility': 'Xiangyang Central Hospital', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinhai tang', 'role': 'CONTACT'}], 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fujian Liu', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Linyi', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingfen Wang', 'role': 'CONTACT'}], 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'city': 'Xi’an', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shuqun Zhang', 'role': 'CONTACT'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '300181', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunxing Song', 'role': 'CONTACT', 'email': 'songyx@sphchina.com', 'phone': '+86 17813230827'}, {'name': 'Zhongsheng Tong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Bengbu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tingjing Yao', 'role': 'CONTACT'}, {'name': 'Huan Zhou', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Bengbu Medical University', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'city': 'Neijiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xujuan Wang', 'role': 'CONTACT'}], 'facility': "The second people's hospital of neijiang", 'geoPoint': {'lat': 29.58354, 'lon': 105.06216}}, {'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yehui Shi', 'role': 'CONTACT'}], 'facility': 'Tianjin Cancer Hospital Airport Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Xingchen Wang', 'role': 'CONTACT', 'email': 'wangxc@sphchina.com', 'phone': '+8615811589825'}], 'overallOfficials': [{'name': 'Binghe Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pharmaceuticals Holding Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}