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