Phase
Condition
N/ATreatment
TQB2102 for injection
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects voluntarily participate in this study, sign informed consent and have goodcompliance.
The age is ≥ 18 years old (subject to the date of signing the informed consent);Female ; eastern cooperative oncology group (ECOG ) score 0-1 ; estimated survivaltime ≥ 3 months ;
Histologically confirmed, unresectable recurrent / metastatic advanced gynecologictumors;
The HER2 expression status (IHC 3+, 2+, 1+ or 0) is confirmed in the tumor tissue,and the subjects with completely negative IHC 0 staining are excluded.
Previous chemotherapy with platinum-based drugs was unsuccessful.
There is at least one measurable lesion according to the RECIST 1.1 criteria; womenof childbearing potential need to meet the following conditions: the serum/urinepregnancy test result is negative before the first administration; they agree toadopt highly effective contraceptive measures (with an annual failure rate of lessthan 1%) throughout the study period. Women of childbearing potential are defined aspremenopausal women who have not had a record of tubal ligation or hysterectomy, orwomen who have been postmenopausal for no more than 1 year.
Exclusion
Exclusion Criteria:
Other malignant tumors occurred within the past 5 years before treatment orcurrently suffered simultaneously.
Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment,excluding alopecia.
Received major surgical treatment, incisional biopsy, or significant traumaticinjury within 28 days before the start of treatment.
Long-term unhealed wounds or fractures.
Subjects with a history of interstitial lung disease/pneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past, or currentlyaccompanied by interstitial lung disease/pneumonia, or those with suspectedinterstitial lung disease/pneumonia indicated by screening imaging and cannot beexcluded.
Subjects with moderate to severe pulmonary dysfunction/disease within 3 monthsbefore the first administration.
Arterial/deep vein thrombosis events occurred within 6 months before treatment, suchas cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.
Subjects with any severe and/or uncontrolled diseases.
Patients with local recurrence suitable for surgery or radiotherapy.
Those with disease progression after receiving chemotherapy drugs of topoisomerase Iinhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors inthe previous first-line treatment.
Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5half-lives before the first administration in this study.
Received treatment with Chinese patent medicines with clear anti-tumor indicationsin the drug instructions approved by National Medical Products Administration (NMPA)within 2 weeks before the first administration in this study.
Serosal effusion that requires repeated drainage to relieve clinical symptoms, orthose who received serosal effusion drainage for treatment purposes within 2 weeksbefore treatment.
Patients with clinically significant tumor bleeding or perforation within 1 monthbefore the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, orpatients with bleeding or coagulation disorders who are using warfarin, aspirin, orother antiplatelet aggregation drugs.
Subjects with known central nervous system metastasis and/or carcinomatousmeningitis, with diffuse dissemination. Subjects with a history of brain metastasismay be considered for inclusion if clinically stable.
Severe bone damage and spinal cord compression caused by tumor bone metastasis,including weight-bearing bone pathological fractures that occurred within 6 monthsor are likely to occur in the near future, poorly controlled severe bone pain, etc.
Those allergic to macromolecular drug components or allergic to any research drug,any component or excipient in the drug.
Received live attenuated vaccines within 4 weeks before treatment.
Active autoimmune diseases that required systemic treatment (such as usingdisease-modifying drugs, corticosteroids, or immunosuppressants) within 2 yearsbefore the first administration.
Received systemic glucocorticoid treatment or any other form of immunosuppressivetherapy or diagnosed with immunodeficiency within 2 weeks before treatment.
Study Design
Connect with a study center
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing 100021
ChinaSite Not Available
Chongqing University Cancer Hospital
Chongqing, Chongqing 400030
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaActive - Recruiting
Fujian Provincial Maternal and Child Health Hospital
Fuzhou, Fujian 350000
ChinaSite Not Available
GanSu Cancer Hospital
Lanzhou, Gansu 730050
ChinaSite Not Available
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong 510623
ChinaSite Not Available
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
Meizhou peoples Hospital
Meizhou, Guangdong 514000
ChinaSite Not Available
Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong 511518
ChinaActive - Recruiting
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong 511518
ChinaSite Not Available
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 53000
ChinaSite Not Available
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaSite Not Available
Tangshan People's Hospital
Tangshan, Hebei 63000
ChinaSite Not Available
Harbin Medical University Cancer Hostipal
Harbin, Heilongjiang 150040
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450000
ChinaSite Not Available
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450014
ChinaSite Not Available
Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430000
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaSite Not Available
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi 330077
ChinaSite Not Available
Jilin Cancer Hospital
Changchun, Jilin 130012
ChinaSite Not Available
Jilin Provincial People's Hospital
Changchun, Jilin 130021
ChinaSite Not Available
Meihekou Central Hospital
Meihekou, Jilin 135000
ChinaSite Not Available
Liaoning Cancer Hospital
Shenyang, Liaoning 110044
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi 710000
ChinaSite Not Available
Fudan University Shanghai Cancer center
Shanghai, Shanghai 200032
ChinaSite Not Available
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai 200090
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiaotong University School of Med
Shanghai, Shanghai 200025
ChinaSite Not Available
West China Second Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
Xinjiang Medical University Affiliated Cancer Hospital
Urumqi, Xinjiang 830011
ChinaSite Not Available
ZheJiang Cancer Hospital
Hangzhou, Zhejiang 310022
ChinaSite Not Available
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