Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 6:08 AM
Study NCT ID:
NCT05114759
Status:
UNKNOWN
Last Update Posted:
2022-10-12
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm study of SHR-A2009'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-09', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) or maximum administered dose (MAD).', 'timeFrame': 'From Day 1 to Day 21', 'description': 'Incidence and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SHR-A2009 treatment.'}, {'measure': 'Recommended Phase 2 dose (RP2D)', 'timeFrame': 'From Day 1 to 90 days after last dose', 'description': 'RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages.'}, {'measure': 'Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)', 'timeFrame': 'From Day 1 to 90 days after last dose', 'description': 'Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0).'}], 'secondaryOutcomes': [{'measure': 'Tmax of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'Time to maximum concentration of SHR-A2009'}, {'measure': 'Cmax of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'Maximum concentration of SHR-A2009'}, {'measure': 'AUC0-t of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009'}, {'measure': 'AUC0-∞ of SHR-A2009', 'timeFrame': 'approximately 6 months', 'description': 'area under the concentration-time curve from time 0 to infinity of SHR-A2009'}, {'measure': 'Immunogenicity of SHR-A2009', 'timeFrame': 'approximately 9 months', 'description': 'Anti-SHR-A2009 antibody (ADA)'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'approximately within 36 months', 'description': 'Evaluated using RECIST 1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;\n2. Have at least one measurable tumor lesion per RECIST v1.1 (patients with only non-target lesions are allowed to be enrolled in dose escalation stage);\n3. ECOG performance status of 0-1;\n4. Life expectancy ≥ 12 weeks;\n5. Adequate bone marrow and organ function .\n6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Patients with symptomatic central nervous system metastases or meningeal metastases;\n2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;\n3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;\n4. History of serious cardiovascular and cerebrovascular diseases;\n5. Severe infection within 4 weeks prior to the first dose;\n6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.'}, 'identificationModule': {'nctId': 'NCT05114759', 'briefTitle': 'A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-A2009-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned.', 'interventionNames': ['Drug: SHR-A2009']}], 'interventions': [{'name': 'SHR-A2009', 'type': 'DRUG', 'description': 'In dose Escalation:\n\nSHR-A2009 will be administered intravenously. Six dose levels are preset.\n\nIn dose Expansion:\n\n2 to 3 dose cohorts will be selected for dose expansion stage.\n\nIn indication Expansion:\n\nIndications will be selected to evaluate preliminary efficacy.', 'armGroupLabels': ['SHR-A2009 for Injection will be administrated per dose level in which the patients are assigned.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400000', 'city': 'Chongqicun', 'state': 'Chongqi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongsheng Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 27.00883, 'lon': 117.18142}}, {'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gen Lin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fujian Provincial Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yilong Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qing Zhou', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Anwen Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jian Li', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '132000', 'city': 'Changchun', 'state': 'Jlin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiuwei Cui', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Hospital of JiLin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shuqin Ni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Cancer Hospital&Institute', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '710000', 'city': 'Xi’an', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haichuan Su', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Air Force Military University Tangdu Hospital', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenxiu Yao', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sichuan Cancer Hospital & Institute', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610000', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'West China Hospital,Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Liang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '277-8577', 'city': 'Chiba', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yasutoshi Kuboki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '104-0045', 'city': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Noboru Yamamoto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '03080', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sae-won Han', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Bae Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong Mu Sun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Wei Shi, MD, PhD', 'role': 'CONTACT', 'email': 'wei.shi@hengrui.com', 'phone': '+86 021-61053363'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}