Status:

RECRUITING

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

Lead Sponsor:

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

Conditions:

Gynecological Tumors

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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, whi...

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.

Key Trial Info

Start Date :

March 13 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT06798207

Start Date

March 13 2025

End Date

November 1 2026

Last Update

July 18 2025

Active Locations (31)

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Page 1 of 8 (31 locations)

1

Cancer Hospital Chinise Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

2

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China, 400030

3

Fujian Provincial Maternal and Child Health Hospital

Fuzhou, Fujian, China, 350000

4

Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014