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NCT07256236PHASE2RECRUITING

SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer

A Single-arm, Multicenter, Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With QL1706 for Recurrent or Metastatic Cervical Cancer

Sponsor: Fujian Cancer Hospital

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Cervical Cancer
Interventions
Sacituzumab tirumotecan, QL1706
Enrollment
89 participants
Primary completion
Jun 2028
Study completion
Dec 2028
First posted
Dec 2025
Last updated
Mar 2026

Primary Endpoints (CT.gov)

Objective Response Rate (ORR)

Time frame: Up to approximately 24 months

Secondary Endpoints

Overall Survival(OS)

Progression Free Survival(PFS)

Duration of Response(DoR)

Eligibility Criteria

Inclusion Criteria: * Female, aged ≥18 years at the time of signing the informed consent form; * Diagnosed with recurrent or metastatic cervical cancer \[pathological types include squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, etc., with pathological report provided\], and not suitable for radical treatments such as surgery or radiotherapy. Patients will be divided into the following two cohorts based on pathological type: * Cohort 1: Cervical squamous cell carcinoma; * Cohort 2: Cervical non-squamous carcinoma (including adenocarcinoma or adenosquamous carcinoma, and other types of cervical cancer) * 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. Specific requiremen

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov