To explore the efficacy and safety of administrating QL1706 in patients with recurrent and/or metastatic cervical cancer who had developed resistance to prior PD-1/PD-L1 antibody therapies.
Patients with recurrent/metastatic cervical cancer who previously experienced failure of PD-1 blockade therapy;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Life expectancy ≥3 months;
Absolute neutrophil count (ANC) ≥1.0×10⁹/L
Prior treatment with anti-PD-1/CTLA-4 bispecific antibodies;
Active autoimmune disease requiring systemic control with corticosteroids (≥10 mg/day prednisone equivalent) or immunosuppressants within 14 days prior to enrollment;
Acute myocardial infarction
Unstable angina
Single group
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
DrugEnrolled patients will receive intravenous infusion of QL1706 once every 3 weeks at a dose of 5.0 mg/kg until disease progression, death, intolerable treatment toxicity, or withdrawal from the clinical trial for any reason.
ORR
The objective response rate (ORR) assessed by the Independent Review Committee (IRC) (according to RECIST v1.1).
DOR
The duration of response (DOR) assessed according to RECIST v1.1.
DCR
The disease control rate (DCR) assessed according to RECIST v1.1
OS
Time from diagnosis of disease to death due to any cause
PFS
Time from diagnosis of disease to disease progression or death due to any cause
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