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

Last updated: March 18, 2025
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

TQB2102 for injection

Clinical Study ID

NCT06798207
TQB2102-II-05
  • Ages > 18
  • Female

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects voluntarily participate in this study, sign informed consent and have goodcompliance.

  • 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 survivaltime ≥ 3 months ;

  • Histologically confirmed, unresectable recurrent / metastatic advanced gynecologictumors;

  • 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; womenof childbearing potential need to meet the following conditions: the serum/urinepregnancy test result is negative before the first administration; they agree toadopt highly effective contraceptive measures (with an annual failure rate of lessthan 1%) throughout the study period. Women of childbearing potential are defined aspremenopausal women who have not had a record of tubal ligation or hysterectomy, orwomen who have been postmenopausal for no more than 1 year.

Exclusion

Exclusion Criteria:

  • Other malignant tumors occurred within the past 5 years before treatment orcurrently suffered simultaneously.

  • Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment,excluding alopecia.

  • Received major surgical treatment, incisional biopsy, or significant traumaticinjury 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 currentlyaccompanied by interstitial lung disease/pneumonia, or those with suspectedinterstitial lung disease/pneumonia indicated by screening imaging and cannot beexcluded.

  • Subjects with moderate to severe pulmonary dysfunction/disease within 3 monthsbefore the first administration.

  • Arterial/deep vein thrombosis events occurred within 6 months before treatment, suchas 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 Iinhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors inthe previous first-line treatment.

  • Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5half-lives before the first administration in this study.

  • Received treatment with Chinese patent medicines with clear anti-tumor indicationsin 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, orthose who received serosal effusion drainage for treatment purposes within 2 weeksbefore treatment.

  • Patients with clinically significant tumor bleeding or perforation within 1 monthbefore the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, orpatients with bleeding or coagulation disorders who are using warfarin, aspirin, orother antiplatelet aggregation drugs.

  • Subjects with known central nervous system metastasis and/or carcinomatousmeningitis, with diffuse dissemination. Subjects with a history of brain metastasismay 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 monthsor 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 usingdisease-modifying drugs, corticosteroids, or immunosuppressants) within 2 yearsbefore the first administration.

  • Received systemic glucocorticoid treatment or any other form of immunosuppressivetherapy or diagnosed with immunodeficiency within 2 weeks before treatment.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: TQB2102 for injection
Phase: 2
Study Start date:
March 13, 2025
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Cancer Hospital Chinise Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Fujian Provincial Maternal and Child Health Hospital

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • GanSu Cancer Hospital

    Lanzhou, Gansu 730050
    China

    Site Not Available

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong 510623
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • Meizhou peoples Hospital

    Meizhou, Guangdong 514000
    China

    Site Not Available

  • Affiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital

    Qingyuan, Guangdong 511518
    China

    Active - Recruiting

  • Affiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital

    Qingyuan, Guangdong 511518
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 53000
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • Tangshan People's Hospital

    Tangshan, Hebei 63000
    China

    Site Not Available

  • Harbin Medical University Cancer Hostipal

    Harbin, Heilongjiang 150040
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450014
    China

    Site Not Available

  • Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Jiangxi Maternal and Child Health Hospital

    Nanchang, Jiangxi 330077
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jilin 130012
    China

    Site Not Available

  • Jilin Provincial People's Hospital

    Changchun, Jilin 130021
    China

    Site Not Available

  • Meihekou Central Hospital

    Meihekou, Jilin 135000
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110044
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi 710000
    China

    Site Not Available

  • Fudan University Shanghai Cancer center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai 200090
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiaotong University School of Med

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • West China Second Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Xinjiang Medical University Affiliated Cancer Hospital

    Urumqi, Xinjiang 830011
    China

    Site Not Available

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

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