a clinical trial of tqb2102 for injection in gynecological tumors with recurrent/metastatic advanced

Conditions: Gynecological Tumors

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 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.