This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer
This is a Phase II, Single-Arm ,multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer.The HER2-expressing is defined as: the HER2 IHC 3+ or 2+, or 1+.subjects with IHC 2+ require testing for FISH.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
2.0 mg/kg IV every 2 weeks
240mg IV every 2 weeks
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
NOT_YET_RECRUITINGBeijing Obstetrics and Gynecology Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Safety run-in :Safety(adverse event)
to evaluate safety including adverse event rate and adverse event grade.
Time frame: Up to approximately 2 years
Dose extension period :Objective Response Rate (ORR)
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed
Time frame: Up to approximately 2 years
Objective Response Rate(ORR)
The objective response rate will be mainly analyzed by according to the RECIST 1.1 standard tumor evaluation by the investigator will be performed
Time frame: Up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Time frame: Up to approximately 2 years
Disease Control Rate(DCR)
Proportion of patients whose tumors shrank or stabilized for a certain period of time
Time frame: Up to approximately 2 years
Progression-free survival (PFS), evaluated by the investigator
Progression-free survival (PFS) refers to the time from the date of first administration to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Time frame: Up to approximately 2 years
Overall survival (OS)
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGGuangxi Tumor Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGJiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGLiaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
NOT_YET_RECRUITINGShandong Cancer Hospital & Institute
Jinan, Shandong, China
NOT_YET_RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGTianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITING...and 2 more locations
Overall survival (OS) refers to the time from the date of first administration to the date of death of the subject.
Time frame: Up to approximately 2 years