Gynecological TumorsPhase 2NCT06798207
A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced
A Phase 2 study testing TQB2102 for injection in people with Gynecological Tumors, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 31 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecological Tumors
- What is being tested?
- TQB2102 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 31 sitesChina
- Study dates
- 13 Mar 2025to Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
China31 sites, 31 recruiting
- Not yet recruiting
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Guangwen Yuan, Doctor, 13693684116, liningnci@126.com
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130012
Yanling Liu, Bachelor, 13500891447, 1301878994@qq.com
- Not yet recruiting
Jilin Provincial People's Hospital
Changchun, Jilin, 130021
Tieying Zhang, Master, 18243074998, zhangtieying2008@163.com
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Ziyi Wang, Doctor, 18692216966, wangziyi@hnca.cn
- Not yet recruiting
West China Second Hospital of Sichuan University
Chengdu, Sichuan, 610041
QingLi Li, Doctor, 18180609168, liqingli73@163.com
- Not yet recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Ying Tang, Master, 13983250752, 2645264434@qq.com
- Not yet recruiting
Fujian Provincial Maternal and Child Health Hospital
Fuzhou, Fujian, 350000
Wenzheng Fang, Doctor, 13705919689, 1518545146@qq.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yang Sun, Doctor, 15959028989, doctorsunyang@sina.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jundong Li, Master, 13602859865, lijd@sysucc.org.cn
- Not yet recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
Liangqing Yao, Doctor, 13916644444, yaoliangqing@163.com
- Not yet recruiting
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Tao Zhu, Master, 13858065156, zhutao@zjcc.org.cn
- Not yet recruiting
Harbin Medical University Cancer Hostipal
Harbin, Heilongjiang, 150040
Xiuwei Chen, Doctor, 13945187909, cxwlcsy@163.com
- Not yet recruiting
GanSu Cancer Hospital
Lanzhou, Gansu, 730050
Qingming Zhang, Bachelor, 13321339133, 1043536297@qq.com
- Not yet recruiting
Meihekou Central Hospital
Meihekou, Jilin, 135000
Shuang Leng, Bachelor, 15143549635, 7746258072@qq.com
- Not yet recruiting
Meizhou peoples Hospital
Meizhou, Guangdong, 514000
Yibiao Chen, Bachelor, 13751962821, cybhtyy812@163.com
- Not yet recruiting
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, 330077
Linsheng He, Doctor, 13979157930, jyfck@163.com
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 53000
Desheng Yao, Doctor, 13978858596, yaodesheng@gxmu.edu.cn
- Recruiting
Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, 511518
Qinglan Hu, Bachelor, 13922608098, qyhuqinglan@163.com
- Not yet recruiting
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, 511518
Weiyan Zhu, Master, 13926666177, 13926666177@139.com
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Med
Shanghai, Shanghai Municipality, 200025
Weiwei Feng, Doctor, 13918551061, fww12066@rjh.com.cn
- Not yet recruiting
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, 200032
Guihao Ke, Doctor, 15921825950, kegh5734@126.com
- Not yet recruiting
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200090
Xuezhen Luo, Doctor, 13472887368, xuezhenluo2013@163.com
- Not yet recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110044
Zhuo Yang, Doctor, 18900945761, zy22245149@163.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xiaomei Fan, Doctor, 15830977999, 15830977999@163.com
- Not yet recruiting
Tangshan People's Hospital
Tangshan, Hebei, 63000
Ping Wang, Doctor, 18931505881, wangshjzh@163.com
- Not yet recruiting
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Ke Wang, Master, 18622221098, 18622080116@163.com
- Not yet recruiting
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, 830011
GuZhaLiNuEr ABuLiZi, Master, 18999999420, gzlnr@qq.com
- Not yet recruiting
Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Guiling Li, Doctor, 13307187507, Lgl6714@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000
Ruifang An, Doctor, 18991232090, anruifang@163.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Liping Han, Doctor, 13619845906, hanliping0825@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450014
Jiamei Yang, Master, 13613863516, yjm6601@163.com
About this study
Official title: 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
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
- Gynecological Tumors
- Being tested
- TQB2102 for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 for injectionDrug
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC).
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for injection | Experimental | Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle Receives: Drug: TQB2102 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)
Measured: Baseline up to 12 months
Secondary outcomes (7)
Duration of remission (DOR)
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Measured: Baseline up to 12 months
Progression-free survival (PFS)
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
Measured: Baseline up to 12 months
Overall survival (OS)
OS defined as the time from the first injection to death from any cause.
Measured: Baseline up to 17 months
Disease control rate (DCR)
DCR defined as percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).
Measured: Baseline up to 12 months
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first
Severity of adverse event (AE)
The severity of all adverse medical events after the first injection.
Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA).
Measured: Before infusion on cycle1 day1, cycle2 day1,cycle 4 day1, cycle7 day1, cycle12 day1 (each cycle is 21 days), 30 days after the end of the last infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start13 Mar 2025
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecological TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798207
- Sponsor's protocol ID
- TQB2102-II-05
- Status last verified
- Dec 2024
- First submitted
- 23 Jan 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No