Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT05765032
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-26
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-25', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. （Phase 1b）', 'timeFrame': 'up to 21 days of cycle 1'}, {'measure': 'Determination of Recommended Phase II dose (RP2D) （Phase 1b）', 'timeFrame': 'Up to 21 days of cycle 1'}, {'measure': 'Objective Response Rate as Assessed by the Investigator according to RECIST v1.1（Phase II）', 'timeFrame': 'From baseline to progressive disease or death (approximately 1 year)'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate as Assessed by the Investigator according to RECIST v1.1e (Ph1b only),', 'timeFrame': 'From baseline to progressive disease or death (approximately 1 year)]'}, {'measure': 'Duration of Response as Assessed by the Investigator according to RECIST v1.1', 'timeFrame': 'From baseline to progressive disease or death (approximately 1 year)'}, {'measure': 'Disease Control Rate as Assessed by the Investigator according to RECIST v1.1', 'timeFrame': 'From baseline to progressive disease or death (approximately 1 year)'}, {'measure': 'Time to Response as Assessed by the Investigator according to RECIST v1.1', 'timeFrame': 'From baseline to progressive disease or death (approximately 1 year)'}, {'measure': 'Progression-free Survival as Assessed by the Investigator according to RECIST v1.1', 'timeFrame': 'From baseline to progressive disease or death (approximately 1 year)'}, {'measure': 'Overall survival', 'timeFrame': 'approximately 12months after last patient enrolled.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18-75 years;\n2. Be able to provide fresh or archived tumour tissue.\n3. Ph 1b: clinically or pathologically diagnosed advanced solid tumour . Ph II: Histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer\n4. With at least one measurable lesion (in accordance with RECIST v1.1)\n5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.\n6. With a life expectancy ≥ 12 weeks.\n7. Sufficient organ functions.\n8. Women of childbearing potential (WOCBP) and Male subjects whose partner are women of childbearing potential must agree to use a reliable and valid contraceptive method.\n\nExclusion Criteria:\n\n1. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression.\n2. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.\n3. Previous or co-existing malignancies other than cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS), papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years\n4. Hypertension that can not be well controlled through antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.\n5. with any active or known autoimmune disease\n6. with active pulmonary tuberculosis infection'}, 'identificationModule': {'nctId': 'NCT05765032', 'briefTitle': 'Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'An Open Label, Multicenter, Phase Ib/II Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'SHR-A1921-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A1921', 'description': 'A1：SHR-A1921+Adebrelimab A2：SHR-A1921+Carboplatin A3：SHR-A1921+Cisplatin A4：SHR-A1921+Bevacizumab A5：SHR-A1921+Adebrelimab+Carboplatin A6：SHR-A1921+Adebrelimab+Cisplatin B1：SHR-A1921+Adebrelimab B2：SHR-A1921+Adebrelimab+Carboplatin/Cisplatin', 'interventionNames': ['Drug: SHR-A1921；']}], 'interventions': [{'name': 'SHR-A1921；', 'type': 'DRUG', 'description': 'Drug: SHR-A1921 administered as an IV infusion Drug: Adebrelimab administered as an IV infusion Drug: Carboplatin administered as an IV infusion Drug: Cisplatin administered as an IV infusion Drug: Bevacizumab administered as an IV infusion', 'armGroupLabels': ['SHR-A1921']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Medical University Cancer Institute& Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}