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

NCT07141186 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2020250707083952035
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Cervical Cancer Metastatic; Cervical Cancer Recurrent; Cervical Adenocarcinoma; Cervical Cancer Squamous Cell

Keywords

cervical cancer; immunotherapy; PD-1/CTLA-4 bispecific antibody; QL1706; PD-1 resistant

Outcome Measures

Primary Outcomes (1)

• ORR

  The objective response rate (ORR) assessed by the Independent Review Committee (IRC) (according to RECIST v1.1).

  1-year

Secondary Outcomes (5)

• DOR

  1-year

• DCR

  1-year

• OS

  1-year

• PFS

  1-year

• Profile of adverse events

  3 years

Study Arms (1)

PD-1/CTLA-4 bispecific antibody treatment group

EXPERIMENTAL

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.

Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

Interventions

QL1706 (bispecific antibody targeting PD-1 and CLTA-4) DRUG

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.

PD-1/CTLA-4 bispecific antibody treatment group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Zhiyong Yuan

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Li

CONTACT

+86-1551093601; lichen.radonco@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiotherapy Department

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2030
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share