Clinical trial · Interventional
A Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Cervical Cancer
A Single-arm, Open, Multicenter Phase II Trial to Evaluate the Efficacy and Safety of QL1706 in Patients With Recurrent or Metastatic Cervical Cancer
NCT05557565CI-TRIAL-00061074unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, open-label, multicenter, phase II trial to evaluate the efficacy and safety of QL1706 in patients with recurrent or metastatic cervical cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QL1706 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QL1706 injection
- description
- The dosage of QL1706 is 5.0 mg/kg, and QL1706 is administered every 3 weeks (Q3W) by intravenous infusion
- interventionNames
- Drug: QL1706
Primary outcomes (1)
- measure
- The Overall Response Rate (ORR) assessed by the Independent Image Review Board (IRC)
- timeFrame
- Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years
- description
- The ORR assessed by the Independent Image Review Board (IRC) according to RECIST V1.1
Secondary outcomes (4)
- measure
- The Overall Response Rate (ORR) assessed by the investigator according to RECIST V1.1
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The subject will participate voluntarily and sign the informed consent form. * Female, aged ≥18 years when signing the informed consent form. * Recurrent or metastatic cervical cancer (pathological types include squamous cell carcinoma, adenocarcinoma) which is not suitable for radical treatment such as surgery and radiotherapy. * At least one measurable lesion is needed. * The Eastern Collaborative Oncology Group (ECOG) physical status score was 0 or 1. * Adequate reserves of organ function is needed. Exclusion Criteria: * Active autoimmune disease. * Central nervous system (CNS) metastasis. * Concomitant diseases such as cardiovascular and cerebrovascular diseases. * Fistula of female genital tract. * Diseases for which systemic corticosteroids or other immunosuppressive agents are planned to be used during the study treatment. * Previous recipients of immune checkpoint inhibitors. * Received systemic antitumor drugs such as chemotherapy and targeted therapy within 4 weeks before the first use of the experimental drug; Received proprietary Chinese medicine with anti-tumor indications within 2 weeks before the first use of the experimental drug. * Received radical concurrent chemoradiotherapy or adjuvant chemoradiotherapy within 12 weeks before the first use of the investigational drug; Received palliative radiotherapy (e.g., reductive radiotherapy for pain or bleeding) or other local treatments (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 2 weeks before the first use of the investigational drug. * History of immunodeficiency. * History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
References
Publications (1)
- DERIVEDLou H, Zhou Y, Li D, Zhang H, Zhang M, Wang L, Cheng H, Liu Z, Duan W, Feng M, Zhang J, Chen L, Wang D, Yu J, Li C, Wang C, Wang P, Li H, Kang X, Liu J. Iparomlimab and tuvonralimab in previously treated patients with cervical cancer. Cell Rep Med. 2026 Aug 4:102944. doi: 10.1016/j.xcrm.2026.102944. Online ahead of print. PMID 42551432