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.
Single group
TQB2102 for injection
DrugTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC).
Overall response rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)
Duration of remission (DOR)
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Progression-free survival (PFS)
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
Overall survival (OS)
OS defined as the time from the first injection to death from any cause.
Disease control rate (DCR)
DCR defined as percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).
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