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OncoMatch/Clinical Trials/NCT07256236

SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer

Is NCT07256236 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sacituzumab tirumotecan and QL1706 for cervical cancer.

Phase 2RecruitingFujian Cancer HospitalNCT07256236Data as of May 2026

Treatment: Sacituzumab tirumotecan · QL1706This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and QL1706 in the treatment of recurrent or metastatic cervical cancer.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy — recurrent or metastatic

Have experienced failure of at least one prior line of platinum-based standard therapy or intolerance to platinum-based drugs in the recurrent or metastatic setting, or have experienced radiologically confirmed disease progression during or within 6 months after completion (≥4 cycles) of platinum-based neoadjuvant or adjuvant chemotherapy.

Cannot have received: TROP2-targeted therapy

Subjects who have previously received TROP2-targeted therapy

Cannot have received: topoisomerase I inhibitor

any drug containing a topoisomerase I inhibitor, including antibody-drug conjugate (ADC) therapy

Cannot have received: experimental anticancer vaccine

any experimental anticancer vaccine

Cannot have received: drug targeting T-cell co-stimulation pathways

any drug targeting T-cell co-stimulation pathways

Lab requirements

Blood counts

Neutrophil count (NEUT#) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin ≥90 g/L

Kidney function

Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault); Urine protein ≤1+; if urine protein ≥2+, then 24-hour urine protein quantification must be ≤1.0 g

Liver function

AST and ALT ≤2.5 × ULN; for subjects with baseline liver metastases, ALT and AST ≤5 × ULN; Albumin ≥30 g/L; Total bilirubin (TBIL) ≤1.5 × ULN

Cardiac function

LVEF ≥50%

Adequate organ and bone marrow function ... defined as follows: Neutrophil count (NEUT#) ≥1.5×10⁹/L; Platelets (PLT) ≥100×10⁹/L; Hemoglobin ≥90 g/L; AST and ALT ≤2.5 × ULN; for subjects with baseline liver metastases, ALT and AST ≤5 × ULN; Albumin ≥30 g/L; Total bilirubin (TBIL) ≤1.5 × ULN; Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault); Urine protein ≤1+; if urine protein ≥2+, then 24-hour urine protein quantification must be ≤1.0 g; INR, APTT, and PT ≤1.5 × ULN; LVEF ≥50%.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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