Actively Recruiting
A Phase 2 Clinical Trial of TQB2102 for Injection in the Treatment of Patients With Recurrent/Metastatic Advanced Gynecological Tumors to Evaluate the Safety and Efficacy
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2025-07-18
170
Participants Needed
31
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 (HER2) positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.
CONDITIONS
Brief 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...
- Participants must voluntarily agree to participate and sign informed consent with good compliance.
- Female, aged 18 years or older at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Estimated survival time of at least 3 months.
- Histologically confirmed unresectable recurrent or metastatic advanced gynecologic tumors.
- Tumor tissue confirmed for HER2 expression status (IHC 3+, 2+, or 1+); complete negative IHC 0 staining excluded.
- Prior platinum-based chemotherapy was unsuccessful.
- At least one measurable lesion per RECIST 1.1 criteria.
- Women of childbearing potential must have a negative pregnancy test before first dose and agree to use highly effective contraception during the study period.
You will not qualify if you...
- Other malignant tumors diagnosed within the past 5 years or currently present.
- 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/pneumonia requiring steroid treatment or suspected by imaging.
- Moderate to severe pulmonary dysfunction within 3 months before first dose.
- Arterial or deep vein thrombosis events within 6 months before treatment.
- Severe or uncontrolled diseases.
- Local tumor recurrence suitable for surgery or radiotherapy.
- Disease progression after prior topoisomerase I inhibitor chemotherapy or similar ADC drugs.
- Anti-cancer therapy or experimental drug use within 28 days or 5 half-lives before first dose.
- Use of Chinese patent medicines with anti-tumor effects within 2 weeks before first dose.
- Serosal effusion requiring repeated drainage or drainage within 2 weeks before treatment.
- Clinically significant tumor bleeding or perforation within 1 month before treatment, or severe bleeding/coagulation disorders.
- Known central nervous system metastasis or carcinomatous meningitis with diffuse spread; stable brain metastasis may be considered.
- Severe bone damage or spinal cord compression from tumor metastasis within 6 months or likely to occur.
- Allergy to macromolecular drugs or any drug components.
- Receipt of live attenuated vaccines within 4 weeks before treatment.
- Active autoimmune diseases requiring systemic treatment within 2 years before first dose.
- Systemic glucocorticoid or immunosuppressive therapy, or immunodeficiency within 2 weeks before treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive TQB2102 for injection by intravenous infusion every 3 weeks as a treatment cycle.
Infusions every 3 weeks with assessments before specified cycles and up to 12 months
Duration - Up to 5 months after treatment
Participants are monitored for safety and long-term outcomes after treatment ends.
Assessments up to 28 days after last dosing and at 30 days post last infusion for antibody testing
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
Y
Yang Sun, Doctor
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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