Treatment of advanced gynecological tumors with TQB2102 injection
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
Run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · NCT06798207 · Data updated 2026-11-12
This study is testing a new injection called TQB2102 to see if it can help people with advanced gynecological tumors feel better while causing fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 170 (estimated) |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 31 sites (Beijing, Beijing Municipality and 30 other locations) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | May 2026 |
| Study ends | November 2026 |
| Registry record updated | July 18, 2025 |
| Trial ID | NCT06798207 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older with unresectable recurrent or metastatic advanced gynecological tumors that express HER2.
✕Probably not a fit
Patients with completely negative HER2 expression (IHC 0) or those who have not previously failed platinum-based chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 clinical trial evaluates the efficacy and safety of TQB2102, an antibody-drug conjugate targeting HER2, in patients with recurrent or metastatic advanced gynecological tumors. The study aims to leverage the targeted delivery of a potent drug payload to tumor cells, minimizing systemic toxicity. Participants will receive TQB2102 injections and will be monitored for treatment response and safety outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with advanced gynecological tumors.
How similar studies have gone: Other studies involving antibody-drug conjugates targeting HER2 have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Fujian Cancer Hospital
Fuzhou, Fujian, China Recruiting -
Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China Recruiting -
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, China Not yet recruiting -
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China Not yet recruiting -
Fujian Provincial Maternal and Child Health Hospital
Fuzhou, Fujian, China Not yet recruiting -
GanSu Cancer Hospital
Lanzhou, Gansu, China Not yet recruiting
Show 25 more locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China Not yet recruiting -
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China Not yet recruiting -
Meizhou peoples Hospital
Meizhou, Guangdong, China Not yet recruiting -
Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China Not yet recruiting -
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China Not yet recruiting -
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China Not yet recruiting -
Tangshan People's Hospital
Tangshan, Hebei, China Not yet recruiting -
Harbin Medical University Cancer Hostipal
Harbin, Heilongjiang, China Not yet recruiting -
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Not yet recruiting -
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Not yet recruiting -
Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China Not yet recruiting -
Hunan Cancer Hospital
Changsha, Hunan, China Not yet recruiting -
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China Not yet recruiting -
Jilin Cancer Hospital
Changchun, Jilin, China Not yet recruiting -
Jilin Provincial People's Hospital
Changchun, Jilin, China Not yet recruiting -
Meihekou Central Hospital
Meihekou, Jilin, China Not yet recruiting -
Liaoning Cancer Hospital
Shenyang, Liaoning, China Not yet recruiting -
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, China Not yet recruiting -
Ruijin Hospital, Shanghai Jiaotong University School of Med
Shanghai, Shanghai Municipality, China Not yet recruiting -
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China Not yet recruiting -
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China Not yet recruiting -
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China Not yet recruiting -
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China Not yet recruiting -
Xinjiang Medical University Affiliated Cancer Hospital
Ürümqi, Xinjiang, China Not yet recruiting -
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, China Not yet recruiting
Study contacts
- Study coordinator: Jundong Li, Master
- Email: lijd@sysucc.org.cn
- Phone: 13602859865
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.