Ignite Creation Date:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2026-02-03 @ 9:47 AM
Study NCT ID:
NCT05353361
Status:
RECRUITING
Last Update Posted:
2023-09-15
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a multicenter, open-label, dose exploration and efficacy expansion phase Ib / II study. The first stage is the dose exploration phase, which uses the 3 + 3 escalation design; The second stage is the curative effect expansion phase.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 402}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT（Phase I (dose exploration phase) ）', 'timeFrame': '21 days after the first administration of each subject'}, {'measure': 'AE（Phase I (dose exploration phase) ）', 'timeFrame': 'from Day1 to 40 or 90 days after last dose'}, {'measure': 'Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）', 'timeFrame': 'from Day1 to 40 or 90 days after last dose'}, {'measure': 'Objective response rate（Phase II (efficacy expansion phase)）', 'timeFrame': 'Two years after the last subject was enrolled in the group'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Immunogenicity of SHR-A1811（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Immunogenicity of Adebrelimab（Phase I secondary endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Objective Response Rate（Phase I secondary endpoint）', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'Duration of response（Phase I secondary endpoint）', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'Progression Free Survival（Phase I secondary endpoint）', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'AE（Phase II secondary study endpoint）', 'timeFrame': 'from Day1 to 40 or 90 days after last dose'}, {'measure': 'Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）', 'timeFrame': 'from Day1 to 40 or 90 days after last dose'}, {'measure': 'PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Immunogenicity of SHR-A1811（Phase II secondary study endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Immunogenicity of Adebrelimab（Phase II secondary study endpoint）', 'timeFrame': 'through study completion, an average of 2 years'}, {'measure': 'Duration of response（Phase II secondary study endpoint）', 'timeFrame': 'from first dose to disease progression or death, whichever comes first, up to 3 years'}, {'measure': 'Progression Free Survival（Phase II secondary study endpoint）', 'timeFrame': 'from first dose to disease progression, or death, whichever comes first, up to 3 years'}, {'measure': 'Event-Free Survival Rate（Phase II secondary study endpoint）', 'timeFrame': 'from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women aged 18 to 75 (inclusive)\n2. Breast cancer confirmed by histology or cytology.\n3. ECOG score is 0 or 1\n4. An expected survival of ≥ 12 weeks\n5. At least one measurable lesion according to RECIST v1.1 criteria\n6. Have adequate renal and hepatic function\n7. Patients voluntarily joined the study and signed informed consent\n\nExclusion Criteria:\n\n1. Have other malignancies within the past 5 years\n2. Active central nervous system metastasis without surgery or radiotherapy\n3. Presence with uncontrollable third space effusion\n4. Have undergone other anti-tumor treatment within 4 weeks before the first dose\n5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose\n6. Any active autoimmune disease or a history of autoimmune disease\n7. A history of immune deficiency\n8. Clinically significant cardiovascular disorders\n9. Clinically significant history of lung disease\n10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I\n11. Known hereditary or acquired bleeding tendency\n12. Active hepatitis and liver cirrhosis\n13. Presence of other serious physical or mental diseases or laboratory abnormalities'}, 'identificationModule': {'nctId': 'NCT05353361', 'briefTitle': 'A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer', 'orgStudyIdInfo': {'id': 'SHR-A1811-II-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-A1811combined Pyrotinib', 'interventionNames': ['Drug: SHR-A1811：Pyrotinib']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-A1811Combined Pertuzumab', 'interventionNames': ['Drug: SHR-A1811；Pertuzumab']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-A1811Combined Adebrelimab', 'interventionNames': ['Drug: SHR-A1811；Adebrelimab']}, {'type': 'EXPERIMENTAL', 'label': 'SHR-A1811Combined Albumin-bound Paclitaxel', 'interventionNames': ['Drug: SHR-A1811；Albumin paclitaxel']}], 'interventions': [{'name': 'SHR-A1811：Pyrotinib', 'type': 'DRUG', 'description': 'SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral', 'armGroupLabels': ['SHR-A1811combined Pyrotinib']}, {'name': 'SHR-A1811；Pertuzumab', 'type': 'DRUG', 'description': 'SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip', 'armGroupLabels': ['SHR-A1811Combined Pertuzumab']}, {'name': 'SHR-A1811；Adebrelimab', 'type': 'DRUG', 'description': 'SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip', 'armGroupLabels': ['SHR-A1811Combined Adebrelimab']}, {'name': 'SHR-A1811；Albumin paclitaxel', 'type': 'DRUG', 'description': 'SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip', 'armGroupLabels': ['SHR-A1811Combined Albumin-bound Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongmei Yin', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jinhai Tang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Jiangsu Provincial People's Hospital", 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xiaoxue Pi', 'role': 'CONTACT', 'email': 'Xiaoxue.pi@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}