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Not Yet RecruitingNCT07141186

QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1/PD-L1 Antibody Therapy

A Prospective, Single-Arm, Phase II Trial of QL1706 in Patients With Recurrent and/or Metastatic Cervical Cancer Who Had Developed Resistance to Prior PD-1/PD-L1 Antibody Therapy

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Tianjin Medical University Cancer Institute and Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

The application of PD-1/PD-L1 antibodies in cervical cancer is becoming increasingly widespread. However, monotherapy with PD-1 inhibitors demonstrates only a 10-20% response rate and a median progression-free survival of merely 2 months in patients with recurrent or metastatic cervical cancer. To address the issue of resistance to PD-1/PD-L1 antibodies in cervical cancer patients, we plan to conduct a clinical study. This study will administer a PD-1/CTLA-4 bispecific antibody to patients with recurrent or metastatic cervical cancer who are resistant to PD-1/PD-L1 therapy, thereby evaluating the efficacy and safety profile of the bispecific antibody in this specific patient population.

Conditions

Interventions

TypeNameDescription
DRUGQL1706 (bispecific antibody targeting PD-1 and CLTA-4)Enrolled 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.

Timeline

Start date
2025-10-01
Primary completion
2027-10-01
Completion
2030-10-01
First posted
2025-08-26
Last updated
2025-08-26

Source: ClinicalTrials.gov record NCT07141186. Inclusion in this directory is not an endorsement.