Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-26 @ 8:04 PM
Study NCT ID:
NCT06108492
Status:
RECRUITING
Last Update Posted:
2024-12-03
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
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': 'This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities (DLTs)', 'timeFrame': 'From Day 1 to Day 21'}, {'measure': 'Maximum tolerated dose (MTD)', 'timeFrame': 'From Day 1 to Day 21'}, {'measure': 'Incidence and severity of adverse events (AEs) ([CTCAE] v5.0)', 'timeFrame': 'From Day 1 to 90 days after last dose'}, {'measure': 'RP2D（Recommended Phase 2 dose）', 'timeFrame': 'From Day 1 to 90 days after last dose'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Tmax of SHR-2005', 'timeFrame': 'approximately 24 months', 'description': 'Time to maximum concentration of SHR-2005'}, {'measure': 'PK parameter: Cmax of SHR-2005', 'timeFrame': 'approximately 24 months', 'description': 'Maximum concentration of SHR-2005'}, {'measure': 'PK parameter: AUC0-∞ of SHR-2005', 'timeFrame': 'approximately 24 months', 'description': 'area under the concentration-time curve from time 0 to infinity of SHR-2005'}, {'measure': 'Immunogenicity of SHR-2005', 'timeFrame': 'approximately 24 months', 'description': 'Anti- SHR-2005 antibody (ADA)'}, {'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'}, {'measure': 'Amount_recovered and Percent_recovered', 'timeFrame': 'approximately 24 months', 'description': 'The Amount \\_ recovered and Percent \\_ recovered of SHR-2005 in urine after intravesical instillation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intermediate and High-risk Non-muscle Invasive Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-2005 for Intravesical perfusion in patients with intermediate and high-risk non-muscle invasive bladder cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n2. ≥18 years of age, either sex;\n3. Previous pathological biopsy was diagnosed as intermediate or high-risk NMIBC ;\n4. ECOG performance status of 0-1;\n5. Life expectancy ≥ 2 years;\n6. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received TURBT or other surgical treatment or radiotherapy for bladder lesions within 2 weeks before the first administration;\n2. Patients who were receiving treatment in other clinical trials or less than 4 weeks from the end of the first administration in this study;\n3. History of serious cardiovascular and cerebrovascular diseases;\n4. Severe infection within 2 weeks prior to the first dose;\n5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0;\n6. Oversize surgery or severe trauma within 4 weeks before the first use of research drugs;\n7. Previously received any TNFR agonist antibody therapy, such as OX40, CD137, CD27, CD357 antibodies.'}, 'identificationModule': {'nctId': 'NCT06108492', 'briefTitle': 'A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I Clinical Study of SHR-2005 Intravesical Instillation in the Treatment of Intermediate and High-risk Non-muscle Invasive Bladder Cancer (NMIBC)', 'orgStudyIdInfo': {'id': 'SHR-2005-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-2005', 'description': 'Only one arm with SHR-2005', 'interventionNames': ['Drug: SHR-2005']}], 'interventions': [{'name': 'SHR-2005', 'type': 'DRUG', 'description': 'In dose Escalation: Four dose levels are preset. The administration cycle included 6 times of induction perfusion period and 15 times of maintenance perfusion period.\n\nIn indication Expansion: Indications will be selected to evaluate preliminary efficacy.', 'armGroupLabels': ['SHR-2005']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianming Guo, Doctor', 'role': 'CONTACT', 'email': 'Guo.jianming@zs-hospital.sh.cn', 'phone': '+86-13681971306'}], 'facility': 'Fudan University Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shouwei Zhao', 'role': 'CONTACT', 'email': 'shouwei.zhao@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}