A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic Advanced

July 16, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinise Academy of Medical Sciences
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Provincial Maternal and Child Health Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Cancer Hospital
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Not yet recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Meizhou, Guangdong, China, 514000
        • Not yet recruiting
        • Meizhou peoples Hospital
        • Contact:
      • Qingyuan, Guangdong, China, 511518
        • Recruiting
        • Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
        • Contact:
      • Qingyuan, Guangdong, China, 511518
        • Not yet recruiting
        • Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 53000
        • Not yet recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
      • Tangshan, Hebei, China, 63000
        • Not yet recruiting
        • Tangshan People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Not yet recruiting
        • Harbin Medical University Cancer Hostipal
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China, 450014
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China, 330077
        • Not yet recruiting
        • Jiangxi Maternal and Child Health Hospital
        • Contact:
          • Linsheng He, Doctor
          • Phone Number: 13979157930
          • Email: jyfck@163.com
    • Jilin
      • Changchun, Jilin, China, 130012
        • Not yet recruiting
        • Jilin Cancer Hospital
        • Contact:
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • Jilin Provincial People's Hospital
        • Contact:
      • Meihekou, Jilin, China, 135000
        • Not yet recruiting
        • Meihekou Central Hospital
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110044
        • Not yet recruiting
        • Liaoning Cancer Hospital
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
      • Shanghai, Shanghai, China, 200025
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Med
        • Contact:
      • Shanghai, Shanghai, China, 200090
        • Not yet recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Second Hospital of Sichuan University
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Hospital
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830011
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Cancer Hospital
        • Contact:
          • GuZhaLiNuEr ABuLiZi, Master
          • Phone Number: 18999999420
          • Email: gzlnr@qq.com
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB2102 for injection
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle
Drug: TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Baseline up to 12 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)
Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of adverse event (AE)
Time Frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
The severity of all adverse medical events after the first injection.
From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Duration of remission (DOR)
Time Frame: Baseline up to 12 months
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Baseline up to 12 months
Progression-free survival (PFS)
Time Frame: Baseline up to 12 months
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
Baseline up to 12 months
Overall survival (OS)
Time Frame: Baseline up to 17 months
OS defined as the time from the first injection to death from any cause.
Baseline up to 17 months
Disease control rate (DCR)
Time Frame: Baseline up to 12 months
DCR defined as percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).
Baseline up to 12 months
Frequency of adverse event (AE)
Time Frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first
The occurrence of all adverse medical events after the first injection.
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)
Time Frame: 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
Incidence of anti-drug antibody (ADA).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 16, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • TQB2102-II-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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