Cervical CancerPhase 2NCT07141186
QL1706 in Patients With Recurrent and Metastatic Cervical Cancer Resistant to Prior PD-1/PD-L1 Antibody Therapy
A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in people with Cervical Cancer and Cervical Cancer Metastatic, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Cancer Metastatic, Cervical Cancer Recurrent
- What is being tested?
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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
- Cervical Cancer, Cervical Cancer Metastatic, Cervical Cancer Recurrent, Cervical Adenocarcinoma, Cervical Cancer Squamous Cell
- Being tested
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
- Keywords
- cervical cancer, immunotherapy, PD-1/CTLA-4 bispecific antibody, QL1706, PD-1 resistant
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The objective response rate (ORR) assessed by the Independent Review Committee (IRC) (according to RECIST v1.1).
Measured: 1-year
Secondary outcomes (5)
DOR
The duration of response (DOR) assessed according to RECIST v1.1.
Measured: 1-year
DCR
The disease control rate (DCR) assessed according to RECIST v1.1
Measured: 1-year
OS
Time from diagnosis of disease to death due to any cause
Measured: 1-year
PFS
Time from diagnosis of disease to disease progression or death due to any cause
Measured: 1-year
Profile of adverse events
Frequency and severity of treatment-related toxicities, whether immune-related or non-immune-related
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiyong Yuan, Tianjin Medical University Cancer Institute and Hospital
- Investigators
- Zhiyong Yuan, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141186
- Sponsor's protocol ID
- 2020250707083952035
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07141186
- Acronym / sponsor ID
- 2020250707083952035
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1/CTLA-4 bispecific antibody treatment group | Experimental | Drug: QL1706 (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (31 listed)
- 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:
- Uncontrolled comorbidities potentially affecting protocol compliance:
- Other malignancies within 3 years (excluding cured BCC, superficial bladder Ca, DCIS, or papillary thyroid Ca);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QL1706 (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. | Drug | PD-1/CTLA-4 bispecific antibody treatment group |
Primary outcome
ORR
Time frame: 1-year
The objective response rate (ORR) assessed by the Independent Review Committee (IRC) (according to RECIST v1.1).
5 secondary outcomes
DOR
Time frame: 1-year
DCR
Time frame: 1-year
OS
Time frame: 1-year
PFS
Time frame: 1-year
Profile of adverse events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiyong Yuan principal investigator
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in people with Cervical Cancer and Cervical Cancer Metastatic, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Li (+86-1551093601, lichen.radonco@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.