A Single-Arm, Open- Label, Multicenter Phase II Study 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 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
• Central laboratory confirmation of HER2 expression: IHC 1+, 2+, or 3+; subjects with IHC 2+ require testing for FISH.
• Central laboratory confirmation of PD-L1 expression
• Measurable disease according to RECIST 1.1 standard
• ECOG physical condition 0 or 1 point
• Adequate organ function, criteria should be met during the screening period
∙ ANC ≥1,500/µL
‣ platelet count ≥100,000/μL
‣ hemoglobin ≥9.0 g/dL
‣ total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for subjects with total bilirubin \>1.5 × ULN. Serum bilirubin ≤3× ULN for subjects with Gilbert's disease
‣ CrCl ≥50 mL/min (measured by the Cockcroft-Gault formula as applicable, or 24-hour urine).
‣ ALT and AST ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases
‣ LVEF ≥\>50%
⁃ Female subjects should be surgically sterilised, post-menopausal or agree to use at least one medically approved contraceptive method during and for 6 months after the end of the study treatment period, must have had a negative blood pregnancy test within 7 days prior to study entry, and must be non-lactating.
⁃ Willingness and ability to comply with trial and follow-up procedure arrangements.