Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06115902
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of TQB2102 for Injection in Patients With Recurrent/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': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Baseline up to 10 months.', 'description': 'ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline up to 14 months.', 'description': 'PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.'}, {'measure': 'Duration of Remission (DOR)', 'timeFrame': 'Baseline up to 14 months.', 'description': 'DOR defined as the time when the participants first achieved complete or partial remission to disease progression.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Baseline up to 10 months.', 'description': 'Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Baseline up to 14 months.', 'description': 'Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD) for ≥ 24 weeks.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline up to 20 months.', 'description': 'OS defined as the time from the first injection to death from any cause.'}, {'measure': 'Incidence of adverse event (AE)', 'timeFrame': 'From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.', 'description': 'The occurrence of all adverse medical events after the first injection.'}, {'measure': 'Severity of adverse event (AE)', 'timeFrame': 'From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.', 'description': 'The severity of all adverse medical events after the first injection.'}, {'measure': 'Concentration of TQB2102', 'timeFrame': '0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.', 'description': 'Serum concentration of TQB2102'}, {'measure': 'Concentration of total antibody', 'timeFrame': '0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.', 'description': 'Total antibody concentration in serum'}, {'measure': 'Small molecule toxin', 'timeFrame': '0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.', 'description': 'Small molecule toxin in plasma'}, {'measure': 'Anti-drug antibody (ADA)', 'timeFrame': 'Before infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, 30 days after the end of the last infusion. Each cycle is 21 days.', 'description': 'Incidence of anti-drug antibody (ADA)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects voluntarily participate in this study and sign informed consent;\n* Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;\n* Breast cancer patients diagnosed with HER2 expression by pathological examination, with evidence of local focal recurrence or distant metastasis, are not suitable for surgery or radiotherapy for cure;\n* Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials;\n* At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);\n* The main organs function are normally;\n* Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* Concomitant disease and medical history:\n\n 1. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;\n 2. Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);\n 3. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;\n 4. Long-term unhealed wounds or fractures;\n 5. Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out;\n 6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;\n 7. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;\n 8. Patients with any severe and/or uncontrolled disease;\n* Tumor related symptoms and treatment:\n\n 1. Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug;\n 2. Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment;\n 3. Patients whose imaging shows that the tumor has invaded important blood vessels or who are determined by the investigators to be highly likely to invade important blood vessels during follow-up studies and cause fatal major bleeding;\n 4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;\n 5. Known presence of cancerous meningitis or clinically active central nervous system metastasis; Patients who have been stable for at least 4 weeks after treatment and have been off corticosteroids for at least 2 weeks are excluded;\n 6. Patients with severe bone injury due to tumor bone metastasis;\n* Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products;\n* Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication;\n* In the judgment of the investigator, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.'}, 'identificationModule': {'nctId': 'NCT06115902', 'briefTitle': 'A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) -Expressing Relapsed/Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'TQB2102-Ib-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQB2102 for injection', 'description': 'Dose: 6.0 mg/kg or 7.5 mg/kg of TQB2102 for injection. Administration: Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.', 'interventionNames': ['Drug: TQB2102 for injection']}], 'interventions': [{'name': 'TQB2102 for injection', 'type': 'DRUG', 'description': 'TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)', 'armGroupLabels': ['TQB2102 for injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changlu Hu, Bachelor', 'role': 'CONTACT', 'email': '13955116061@139.com', 'phone': '13955116061'}], 'facility': 'Anhui Pronvincial Cancer Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '237008', 'city': "Lu'an", 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feng Rong, Master', 'role': 'CONTACT', 'email': 'wazhl1996@163.com', 'phone': '13635649383'}], 'facility': "Lu'an People's Hospital", 'geoPoint': {'lat': 31.73561, 'lon': 116.51688}}, {'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peng Yuan, Doctor', 'role': 'CONTACT', 'email': 'yuanpeng01@hotmail.com', 'phone': '13501270834'}], 'facility': 'Cancer Hospital Chinese Academy of Medical Science', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohua Zeng, Doctor', 'role': 'CONTACT', 'email': 'zxiaohuacqu@126.com', 'phone': '18986340992'}], 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shusen Wang, Doctor', 'role': 'CONTACT', 'email': 'wangshs@sysucc.org.cn', 'phone': '13926168469'}], 'facility': 'Sun Yat-Sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '529000', 'city': 'Jiangmen', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Li, Doctor', 'role': 'CONTACT', 'email': '13600033922@188.com', 'phone': '18933183766'}], 'facility': 'Jiangmen Central Hospital', 'geoPoint': {'lat': 22.58333, 'lon': 113.08333}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'WeiMin Xie, Doctor', 'role': 'CONTACT', 'email': 'xieweimin3358@163.com', 'phone': '13907861028'}], 'facility': 'Guangxi Medical University Cancer Hospital', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingyuan Zhang, Doctor', 'role': 'CONTACT', 'email': '13313612989@163.com', 'phone': '+8613312612989'}], 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '410031', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quchang OuYang, Doctor', 'role': 'CONTACT', 'email': 'oyqc1969@126.com', 'phone': '13973135318'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '341000', 'city': 'Ganzhou', 'state': 'Jiangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Wang, Master', 'role': 'CONTACT', 'email': 'goestbaby@163.com', 'phone': '13807078925'}], 'facility': "Ganzhou People's Hospital", 'geoPoint': {'lat': 25.84664, 'lon': 114.9326}}, {'zip': '130012', 'city': 'Changchun', 'state': 'Jilin', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunjiao Wu, Master', 'role': 'CONTACT', 'email': '2956519672@qq.com', 'phone': '13643112151'}], 'facility': 'Jilin Cancer Hospital', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Sun, Doctor', 'role': 'CONTACT', 'email': 'Inzlrxnsy@163.com', 'phone': '13940404526'}], 'facility': 'Liaoning Cancer Hospital & Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiujuan Qu, Doctor', 'role': 'CONTACT', 'email': 'quxiujuan@hotmail.com', 'phone': '13604031355'}], 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huihui Li, Doctor', 'role': 'CONTACT', 'email': '17653115650@163.com', 'phone': '+86 17653115650'}], 'facility': 'Cancer Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '276034', 'city': 'Linyi', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jingfen Wang, Master', 'role': 'CONTACT', 'email': '2298641960@qq.com', 'phone': '15963976026'}], 'facility': 'Linyi Cancer Hospital', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '710089', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jin Yang, Doctor', 'role': 'CONTACT', 'email': '1473106133@qq.com', 'phone': '18991232383'}], 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '030000', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Luo, Master', 'role': 'CONTACT', 'email': '2435654439@qq.com', 'phone': '13835101051'}], 'facility': 'Shanxi Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '629000', 'city': 'Suining', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongwei Yang, Master', 'role': 'CONTACT', 'email': 'snsyhw@163.com', 'phone': '18008258079'}], 'facility': 'Suining Central Hospital', 'geoPoint': {'lat': 30.50802, 'lon': 105.57332}}, {'zip': '300202', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yehui Shi, Doctor', 'role': 'CONTACT', 'email': 'shiyehui@tjmuch.com', 'phone': '18622221183'}], 'facility': 'Tianjin Medical University Cancer Institute & Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yabing Zheng, Master', 'role': 'CONTACT', 'email': 'zhengyabing@sina.com', 'phone': '13858065353'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Qingyuan Zhang, Doctor', 'role': 'CONTACT', 'email': '13313612989@163.com', 'phone': '+86 13312612989'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}