Treatment of advanced gynecological tumors with TQB2102 injection

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

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
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 31 sites (Beijing, Beijing Municipality and 30 other locations)
• Trial ID: NCT06798207 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with unresectable recurrent or metastatic advanced gynecological tumors that express HER2.

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.

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 performed: Other studies involving antibody-drug conjugates targeting HER2 have shown promising results, indicating potential for success in this approach.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 30 other locations

• 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)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• GanSu Cancer Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• 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 (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

Conditions Gynecological Tumors