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
a)Patients with histologically confirmed HER2-expressing recurrent or metastatic cervical cancer who have failed at least 1 line of standard platinum-containing therapy ; b) Not suitable for surgery or radiotherapy;
Voluntarily agreed to participate in the study and signed an informed consent form.
Female, age ≥ 18 years
Expected survival ≥ 12 weeks
Have central nervous system metastases and/or carcinomatous meningitis.
Received anti-tumour therapy or participated in another clinical study treatment within 4 weeks prior to the start of study treatment.
Toxicity due to previous antineoplastic therapy has not recovered to NCI-CTCAE (version 5.0) grade 0-1.
Major surgery with incomplete recovery within 4 weeks prior to start of study dosing.
Single group
Disitamab Vedotin
Drug2.0 mg/kg IV every 2 weeks
Zimberelimab
Drug240mg IV every 2 weeks
Safety run-in ：Safety(adverse event)
to evaluate safety including adverse event rate and adverse event grade.
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
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
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
Disease Control Rate(DCR)
Proportion of patients whose tumors shrank or stabilized for a certain period of time
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.
Click on the lead sponsor to view all of their trials.
