Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT04165993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-21
First Post:
2019-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Throughout the duration of the study; up to 2 years', 'description': 'Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'up to 2 years', 'description': 'Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest', 'timeFrame': 'Throughout the duration of the study', 'description': 'AEs, SAEs'}, {'measure': 'Progression free survival (PFS) rates', 'timeFrame': '6 months and 12 months', 'description': 'Progression free survival (PFS) rates'}, {'measure': 'Overall survival (OS) rates', 'timeFrame': '6 months and 12 months', 'description': 'Overall survival (OS) rates'}, {'measure': 'durable benefit rate (DBR)', 'timeFrame': 'DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks', 'description': 'durable benefit rate (DBR)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.', 'detailedDescription': 'KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject \\>= 18 years\n* Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast cancer\n* ECOG score 0 or 1\n* Life expectancy \\>3 months\n* According to the definition of RECIST1.1, the patient has at least one measurable lesion\n* Adequate organ function prior to start treatment with KN026\n* Able to understand, voluntarily participate and willing to sign the ICF\n\nExclusion Criteria:\n\n* Accepted any other anti-tumor drug therapies within 4 weeks before fist dose\n* Accepted radiotherapy within 4 weeks before enrollment\n* Subjects are eligible with clinically controlled and stable neurologic function \\>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible\n* Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study\n* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation\n* History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation\n* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage'}, 'identificationModule': {'nctId': 'NCT04165993', 'briefTitle': 'Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu Alphamab Biopharmaceuticals Co., Ltd'}, 'officialTitle': 'Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'KN026-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concurrent chemotherapy and KN026', 'description': 'KN026 combined with docetaxol', 'interventionNames': ['Drug: Concurrent chemotherapy and KN026']}, {'type': 'EXPERIMENTAL', 'label': 'KN026 monotherapy', 'description': 'KN026 monotherapy', 'interventionNames': ['Drug: KN026 monotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'A combination treatment of KN026 and KN046', 'description': 'KN026 combined with KN046', 'interventionNames': ['Drug: KN026 combination']}], 'interventions': [{'name': 'Concurrent chemotherapy and KN026', 'type': 'DRUG', 'otherNames': ['docetaxol'], 'description': '30 mg/kg Q3W KN026 75 mg/m2 docetaxol', 'armGroupLabels': ['Concurrent chemotherapy and KN026']}, {'name': 'KN026 monotherapy', 'type': 'DRUG', 'otherNames': ['KN026'], 'description': '30 mg/kg Q3W KN026', 'armGroupLabels': ['KN026 monotherapy']}, {'name': 'KN026 combination', 'type': 'DRUG', 'otherNames': ['KN046'], 'description': '30 mg/kg Q3W KN026 5 mg/kg Q3W KN046', 'armGroupLabels': ['A combination treatment of KN026 and KN046']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'overallOfficials': [{'name': 'Qingyuan Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Harbin Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu Alphamab Biopharmaceuticals Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}