Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT04276493
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach 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'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726995', 'term': 'zanidatamab'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'C000707970', 'term': 'tislelizumab'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], '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'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'dispFirstSubmitDate': '2024-12-03', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-18', 'dispFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants experiencing Adverse Events (AEs)', 'timeFrame': 'From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months'}, {'measure': 'Number of Participants experiencing Serious Adverse Events (SAEs) as assessed by the investigator.', 'timeFrame': 'From the first dose of study drug(s) to 30 days after the last dose; up to approximately 41 months'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months', 'description': 'Defined as the percentage of participants who had a best overall response of complete response or partial response per the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.'}], 'secondaryOutcomes': [{'measure': 'Duration of response (DOR)', 'timeFrame': 'From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months', 'description': 'Time from the start date of study drug to the first determination of an objective response by investigator per RECIST Version 1.1'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'From the start date of study treatment to the first documentation of progression or death, whichever occurs first, up to approximately 41 months', 'description': 'Percentage of participants with best overall response of complete response, partial response, and stable disease by investigator per RECIST Version 1.1'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'From the start date of study treatment to the documented death date or the last known alive date, up to approximately 41 months', 'description': 'Time from the start date of study drug to the date of death due to any cause'}, {'measure': 'Serum concentration of zanidatamab as a function of time', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Observed maximum plasma concentration of zanidatamab during a sample interval (Cmax)', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Observed time to maximum plasma concentration of zanidatamab during a sampling interval (tmax)', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Terminal elimination half-life (t1/2) of zanidatamab', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the last measurable timepoint (AUC(0-t)) of zanidatamab', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Apparent clearance after oral administration (CL/F) of zanidatamab', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Presence of anti-zanidatamab-antibodies', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Presence of zanidatamab neutralizing antibodies', 'timeFrame': 'Predose and immediately postdose'}, {'measure': 'Number of participants with AEs and SAEs who entered the long-term extension period', 'timeFrame': 'From the first dose of study drug(s) to 30 days after the last dose; up to approximately 51 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer', 'Gastric Cancer', 'Gastroesophageal Junction Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of zanidatamab in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and zanidatamab in combination with tislelizumab and chemotherapy in participants with HER2-positive gastric/gastroesophageal Junction (GEJ) adenocarcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Disease diagnosis and prior treatment:\n\n 1. Cohort 1 (the first-line breast cancer treatment cohort):\n\n * Female participants with histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the breast and candidate for chemotherapy. Locally recurrent disease must not be amenable to resection with curative intent.\n * Human epidermal growth factor receptor 2 (HER2) IHC 3+ or in situ hybridization positive on the archival tumor tissue or fresh biopsy sample.\n * Have not received previous systemic anticancer therapy for locally advanced unresectable or metastatic disease.\n 2. Cohort 2 (the first-line gastric/gastroesophageal junction adenocarcinoma treatment cohort):\n\n * Histologically or cytologically confirmed unresectable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction\n * HER2 IHC 3+ or HER2 IHC 2+ together with in situ hybridization positive on the archival tumor tissue or fresh biopsy sample.\n * Have not received previous systemic anticancer therapy for locally advanced unresectable or metastatic disease, including any approved or investigational estimated glomerular filtration rate (EGFR) or anti-HER2 agents or vaccines, cytotoxic chemotherapy or checkpoint inhibitors\n2. At least 1 measurable lesion as defined per RECIST Version 1.1\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1\n4. Adequate organ function\n5. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram or multigated acquisition scan (MUGA) (echocardiogram is the preferred method) within 28 days before the first dose of study drug\n\nKey Exclusion Criteria:\n\n1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n2. History of approved or investigative tyrosine kinase/HER inhibitors in any treatment setting\n\n a. except trastuzumab with or without pertuzumab used in neoadjuvant or adjuvant setting for Cohort 1\n3. Active leptomeningeal disease, untreated or uncontrolled brain metastasis\n4. Any active malignancy ≤ 2 years before the first dose of study drug, except for the specific cancer under investigation in this trial and any localized cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix)\n5. Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug\n\nNote: Participants who are currently or have previously been on any of the following steroid regimens are not excluded:\n\n1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)\n2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\n3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04276493', 'briefTitle': 'Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'Phase 1b/2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-HER2 Bispecific Antibody ZW25 in Combination With Chemotherapy With/Without Tislelizumab in Patients With Advanced HER2-positive Breast Cancer or Gastric/Gastroesophageal Junction Adenocarcinoma', 'orgStudyIdInfo': {'id': 'BGB-A317-ZW25-101'}, 'secondaryIdInfos': [{'id': 'CTR20210237', 'type': 'OTHER', 'domain': 'ChinaDrugTrials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1- Zanidatamab + Docetaxel', 'description': 'Zanidatamab intravenous (IV) infusion followed by docetaxel IV infusion first-line therapy once every three weeks (Q3W) in female participants with metastatic breast cancer', 'interventionNames': ['Biological: Zanidatamab', 'Drug: Docetaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy', 'description': 'Zanidatamab intravenous (IV) infusion followed by tislelizumab IV infusion and CAPOX chemotherapy (oral capecitabine + IV oxaliplatin) first-line therapy once every three weeks (Q3W) in participants with metastatic gastric / GEJ adenocarcinoma', 'interventionNames': ['Biological: Zanidatamab', 'Biological: Tislelizumab', 'Drug: Capecitabine', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'Zanidatamab', 'type': 'BIOLOGICAL', 'otherNames': ['ZW25'], 'description': 'Administered intravenously', 'armGroupLabels': ['Cohort 1- Zanidatamab + Docetaxel', 'Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Cohort 1- Zanidatamab + Docetaxel']}, {'name': 'Tislelizumab', 'type': 'BIOLOGICAL', 'otherNames': ['BGB-A317'], 'description': 'Administered intravenously', 'armGroupLabels': ['Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Cohort 2- Zanidatamab + Tiselizumab + Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Affiliated Hospital of Military Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Chongqing Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Provincial Peoples Hospital Huifu Branch', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '330009', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Third Hospital of Nanchang', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110042', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Liaoning Cancer Hospital and Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '03080', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Severance Hospital Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06273', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08308', 'city': 'Seoul', 'state': 'Seoul Teugbyeolsi', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '40447', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Hospital', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '100225', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital East Campus', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}