Status:
NOT_YET_RECRUITING
QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1/PD-L1 Antibody Therapy
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Cervical Cancer
Cervical Cancer Metastatic
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 progres...
Eligibility Criteria
Inclusion
- 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;
- At least one measurable lesion per RECIST v1.1:
- Non-lymph node lesion: Longest diameter ≥10 mm Lymph node lesion: Short-axis diameter ≥15 mm Note: Previously irradiated lesions must be outside radiation fields or demonstrate progression post-radiation.
- Adequate organ function within 14 days prior to treatment:
- Absolute neutrophil count (ANC) ≥1.0×10⁹/L
- Hemoglobin ≥60 g/L
- Platelet count ≥50×10⁹/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN (≤5×ULN for hepatic metastasis)
- Serum creatinine ≤2×ULN
- Reproductive requirements:
- Non-childbearing potential (surgically sterilized or postmenopausal) OR
- Women of childbearing potential:
- Negative serum pregnancy test within 7 days prior to enrollment Commitment to use double-barrier contraception throughout the study and for 180 days post-treatment
- Ability to comply with scheduled visits, treatment plans, and laboratory tests;
- Voluntarily signed written informed consent.
Exclusion
- 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;
- Clinically significant cardiovascular/cerebrovascular events within 6 months prior to treatment, including:
- Acute myocardial infarction
- Unstable angina
- Cerebrovascular accident
- Symptomatic arterial/venous thrombosis or ischemic cardiomyopathy
- Clinically significant ventricular arrhythmias (sustained VT, VF, torsades de pointes)
- NYHA Class III/IV heart failure
- QTcF ≥480 ms or congenital long QT syndrome
- LVEF \<50% or severe wall motion abnormality per echocardiography
- Uncontrolled hypertension (SBP \>160 mmHg or DBP \>100 mmHg)
- Other clinically significant arrhythmias (e.g., third-degree AV block);
- Uncontrolled comorbidities potentially affecting protocol compliance:
- Severe respiratory diseases (ILD, severe asthma)
- Active infections:
- HBV (HBsAg+ AND HBV-DNA \>500 IU/mL)
- HCV (HCV-Ab+ AND HCV-RNA+)
- HIV-Ab+
- Active TB or systemic infections requiring treatment ≤14 days
- GI perforation/fistula ≤6 months (exceptions: resolved surgically)
- Clinically significant bleeding ≤1 month (hematemesis, hemoptysis, etc.)
- Active diverticulitis, abdominal abscess, or bowel obstruction;
- Other malignancies within 3 years (excluding cured BCC, superficial bladder Ca, DCIS, or papillary thyroid Ca);
- Known immunodeficiency disorders;
- History of allogeneic hematopoietic stem cell or solid organ transplantation (excluding corneal grafts);
- Systemic infections requiring IV antibiotics \>7 days within 2 weeks prior to treatment;
- Administration of live attenuated vaccines within 4 weeks before/after treatment;
- Pregnancy or lactation;
- Investigator-assessed ineligibility;
- Concurrent participation in other clinical trials.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07141186
Start Date
October 1 2025
End Date
October 1 2030
Last Update
August 26 2025
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