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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
170
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC).
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Provincial Maternal and Child Health Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGOverall response rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)
Time frame: Baseline up to 12 months
Duration of remission (DOR)
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Time frame: Baseline up to 12 months
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.
Time frame: Baseline up to 12 months
Overall survival (OS)
OS defined as the time from the first injection to death from any cause.
Time frame: Baseline up to 17 months
Disease control rate (DCR)
DCR defined as percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).
Time frame: Baseline up to 12 months
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first
Severity of adverse event (AE)
The severity of all adverse medical events after the first injection.
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA).
Time frame: Before infusion on cycle1 day1, cycle2 day1,cycle 4 day1, cycle7 day1, cycle12 day1 (each cycle is 21 days), 30 days after the end of the last infusion
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GanSu Cancer Hospital
Lanzhou, Gansu, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGMeizhou peoples Hospital
Meizhou, Guangdong, China
NOT_YET_RECRUITINGAffiliated Qingyuan Hospital, Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China
RECRUITINGAffiliated Qingyuan Hospital,Guangzhou Medical University,Qingyuan People's Hospital
Qingyuan, Guangdong, China
NOT_YET_RECRUITING...and 21 more locations