Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2025-03-13
Last updated
2025-07-18
Condition(s) studied
Gynecological Tumors
Investigational drug(s) / intervention(s)
TQB2102 for injection
TQB2102 for injection: TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC).
Study summary
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a 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 2 study to evaluate the efficacy,and safety of TQB2102 for injection in recurrent/metastatic advanced gynecological tumors.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects voluntarily participate in this study, sign informed consent and have good compliance.
* 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 survival time ≥ 3 months ;
* Histologically confirmed, unresectable recurrent / metastatic advanced gynecologic tumors;
* 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; women of childbearing potential need to meet the following conditions: the serum/urine pregnancy test result is negative before the first administration; they agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) throughout the study period. Women of childbearing potential are defined as premenopausal women who have not had a record of tubal ligation or hysterectomy, or women who have been postmenopausal for no more than 1 year.
Exclusion Criteria:
* Other malignant tumors occurred within the past 5 years before treatment or currently suffered simultaneously.
* Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment, excluding alopecia.
* Received major surgical treatment, incisional biopsy, or significant traumatic injury 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 currently accompanied by interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening imaging and cannot be excluded.
* Subjects with moderate to severe pulmonary dysfunction/disease within 3 months before the first administration.
* Arterial/deep vein thrombosis events occurred within 6 months before treatment, such as 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 I inhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors in the previous first-line treatment.
* Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5 half-lives before the first administration in this study.
* Received treatment with Chinese patent medicines with clear anti-tumor indications in 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, or those who received serosal effusion drainage for treatment purposes within 2 weeks before treatment.
* Patients with clinically significant tumor bleeding or perforation within 1 month before the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, or patients with bleeding or coagulation disorders who are using warfarin, aspirin, or other antiplatelet aggregation drugs.
* Subjects with known central nervous system metastasis and/or carcinomatous meningitis, with diffuse dissemination. Subjects with a history of brain metastasis may 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 months or 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 using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first administration.
* Received systemic glucocorticoid treatment or any other form of immunosuppressive therapy or diagnosed with immunodeficiency within 2 weeks before treatment.
Primary outcome measure(s)
Overall response rate (ORR) — Baseline up to 12 months ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)
Trial sites (31)
Facility
City
Region
Status
Cancer Hospital Chinise Academy of Medical Sciences
Beijing
Beijing Municipality
Not Yet Recruiting
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Not Yet Recruiting
Fujian Provincial Maternal and Child Health Hospital
Fuzhou
Fujian
Not Yet Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
GanSu Cancer Hospital
Lanzhou
Gansu
Not Yet Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Not Yet Recruiting
Guangzhou Women and Children's Medical Center
Guangzhou
Guangdong
Not Yet Recruiting
Meizhou peoples Hospital
Meizhou
Guangdong
Not Yet Recruiting
Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan
Guangdong
Recruiting
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan
Guangdong
Not Yet Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Guangxi
Not Yet Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Not Yet Recruiting
Tangshan People's Hospital
Tangshan
Hebei
Not Yet Recruiting
Harbin Medical University Cancer Hostipal
Harbin
Heilongjiang
Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Not Yet Recruiting
Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Hubei
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Not Yet Recruiting
Jiangxi Maternal and Child Health Hospital
Nanchang
Jiangxi
Not Yet Recruiting
Jilin Cancer Hospital
Changchun
Jilin
Not Yet Recruiting
Jilin Provincial People's Hospital
Changchun
Jilin
Not Yet Recruiting
Meihekou Central Hospital
Meihekou
Jilin
Not Yet Recruiting
Liaoning Cancer Hospital
Shenyang
Liaoning
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an
Shaanxi
Not Yet Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Med
Shanghai
Shanghai Municipality
Not Yet Recruiting
Fudan University Shanghai Cancer center
Shanghai
Shanghai Municipality
Not Yet Recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai
Shanghai Municipality
Not Yet Recruiting
West China Second Hospital of Sichuan University
Chengdu
Sichuan
Not Yet Recruiting
Tianjin Medical University Cancer Hospital
Tianjin
Tianjin Municipality
Not Yet Recruiting
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi
Xinjiang
Not Yet Recruiting
ZheJiang Cancer Hospital
Hangzhou
Zhejiang
Not Yet Recruiting
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
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