Actively Recruiting
A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-07-18
170
Participants Needed
31
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 years or older with good compliance and voluntary informed consent
- Eastern Cooperative Oncology Group (ECOG) score of 0-1 and estimated survival time of at least 3 months
- Histologically confirmed unresectable recurrent or metastatic advanced gynecologic tumors
- Confirmed HER2 expression status (IHC 1+, 2+, or 3+; excluding completely negative IHC 0)
- Previous platinum-based chemotherapy was unsuccessful
- At least one measurable lesion according to RECIST 1.1 criteria
- Negative serum or urine pregnancy test before first administration for women of childbearing potential
- Agreement to use highly effective contraception throughout the study for women of childbearing potential
You will not qualify if you...
- Other malignant tumors within past 5 years or currently
- Uncontrollable toxic reactions above CTCAE Grade 1 from prior treatments (excluding alopecia)
- Major surgery, incisional biopsy, or significant injury within 28 days before treatment
- Long-term unhealed wounds or fractures
- History or current interstitial lung disease or pneumonia requiring steroid treatment
- Moderate to severe pulmonary dysfunction within 3 months before first administration
- Arterial or deep vein thrombosis events within 6 months before treatment
- Severe or uncontrolled diseases
- Local recurrence suitable for surgery or radiotherapy
- Disease progression after prior treatment with topoisomerase I inhibitors or ADC drugs with topoisomerase I inhibitor toxins
- Anti-cancer therapy or experimental drugs within 28 days or 5 half-lives before first administration
- Use of certain Chinese patent medicines with anti-tumor indications within 2 weeks before treatment
- Serosal effusion requiring repeated drainage or recent drainage within 2 weeks
- Significant tumor bleeding or perforation within 1 month before treatment or bleeding/coagulation disorders requiring certain medications
- Known active central nervous system metastasis or carcinomatous meningitis with diffuse dissemination
- Severe bone damage or spinal cord compression caused by tumor bone metastasis
- Allergy to macromolecular drug components or excipients in study drugs
- Live attenuated vaccine within 4 weeks before treatment
- Active autoimmune diseases requiring systemic treatment within 2 years before first administration
- Systemic glucocorticoid or immunosuppressive treatment or immunodeficiency within 2 weeks before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
3
Fujian Provincial Maternal and Child Health Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
4
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
5
GanSu Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
6
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
7
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China, 510623
Not Yet Recruiting
8
Meizhou peoples Hospital
Meizhou, Guangdong, China, 514000
Not Yet Recruiting
9
Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China, 511518
Actively Recruiting
10
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China, 511518
Not Yet Recruiting
11
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 53000
Not Yet Recruiting
12
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
13
Tangshan People's Hospital
Tangshan, Hebei, China, 63000
Not Yet Recruiting
14
Harbin Medical University Cancer Hostipal
Harbin, Heilongjiang, China, 150040
Not Yet Recruiting
15
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
16
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450014
Not Yet Recruiting
17
Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
18
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Not Yet Recruiting
19
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330077
Not Yet Recruiting
20
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Not Yet Recruiting
21
Jilin Provincial People's Hospital
Changchun, Jilin, China, 130021
Not Yet Recruiting
22
Meihekou Central Hospital
Meihekou, Jilin, China, 135000
Not Yet Recruiting
23
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110044
Not Yet Recruiting
24
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
25
Ruijin Hospital, Shanghai Jiaotong University School of Med
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
26
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
27
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200090
Not Yet Recruiting
28
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
29
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
30
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, China, 830011
Not Yet Recruiting
31
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
J
Jundong Li, Master
CONTACT
Y
Yang Sun, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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