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Cervical CancerPhase 2/3NCT07177716

Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 in Advanced Recurrent/Metastatic Cervical Cancer

A Phase 2/3 study testing LB1410, LB4330 and Lenvatinib in people with Cervical Cancer, run by L & L Bio Co., Ltd., Ningbo, China at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a multicenter, randomized, open-label Phase II/III clinical study, aiming to evaluate the efficacy and safety of LB1410 in combination with lenvatinib (whether in combination with LB4330）versus the chemotherapy regimen selected by the investigators for patients with advanced recurrent/metastatic cervical… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
LB1410, LB4330 and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
Oct 2025to Dec 2028
Phase
Phase 2/3
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

  • Histologically confirmed cervical squamous cell carcinoma, adenosquamous carcinoma, or HPV-associated cervical adenocarcinoma.
  • Recurrent or metastatic cervical cancer with disease progression or intolerable toxicity after standard therapy, with no more than three prior lines of systemic therapy in the recurrent or metastatic setting, with only one prior line of therapy containing anti-PD-1/anti-PD-L1 agents.
  • At least one measurable lesion per RECIST v1.1 at screening period.
  • Age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Investigator-assessed life expectancy ≥12 weeks.
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  • Adequate hematological function, liver function, renal function and coagulation function.
  • Adequately controlled blood pressure (BP) with or without antihypertensive medication.
  • Any related toxicity or prior adverse events (AEs) had recovered to baseline or ≤Grade 1 per NCI CTCAE v5.0.
  • Women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form, throughout the study, and for 6 months after the last dose of study treatment.
  • The patient is capable of understanding and voluntarily signing the informed consent form.

Who cannot join

  • For cohorts containing lenvatinib, patients meeting any of the following criteria are ineligible:
  • Radiographic (CT or MRI) evidence of tumor invasion around major blood vessels, or investigator judgment that the tumor is highly likely to invade major blood vessels during the study, leading to life-threatening hemorrhage;
  • History of bleeding, coagulation disorders, or current use of warfarin, aspirin, or other antiplatelet agents;
  • Urine protein ≥2+ and 24-hour urine protein quantification ≥1.0 g;
  • Factors affecting oral drug absorption;
  • Intestinal metastases or existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistulas;
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  • History of hypertensive crisis or hypertensive encephalopathy.
  • Pregnant or breastfeeding women.
  • History of ≥Grade 3 immune-related adverse events (irAEs) during prior immunotherapy.
  • Active autoimmune disease or symptomatic autoimmune disease.
  • Any of the following prior treatments:
  • Live or attenuated live vaccines within 4 weeks before the first dose;
  • Immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 14 days before the first dose;
  • History of allogeneic organ transplantation, allogeneic peripheral hematopoietic stem cell transplantation, or bone marrow transplantation.
  • Positive HIV test, active syphilis, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection.
  • Other malignancies within the past 3 year.
  • Leptomeningeal metastasis, spinal cord compression, symptomatic or unstable brain metastases.
  • Uncontrolled or poorly controlled diabetes.
  • Arterial/venous thrombotic events within 6 months.
  • Clinically significant and unstable pleural, peritoneal, or pericardial effusion.
  • Known interstitial lung disease.
  • Prior use of drugs with the same mechanism as this study (e.g., PD-1 antibody combined with TIM-3 antibody, PD-1/TIM-3 bispecific antibodies).
  • Any other condition (including severe medical or psychiatric illness) or clinically significant laboratory abnormality that may affect patient safety or study integrity per investigator judgment.
  • (Applicable only to containing-LB4330 cohorts): History of Grade IV thrombocytopenia (per CTCAE) from any prior anti-cancer regimen within the past 2 years, or prior exposure to any interleukin-10 (IL-10) based agent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yan Luan, Doctor contact

86-21-54152522

luanyn2@lnlbio.com

Xiaohua Wu, Doctor contact

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

    Jun Zhu, Doctor, +8613564972482, drzhujun@shca.org.cn

    Xiaohua Wu, Doctor

Other trials in China

About this study

Official title: A Multicenter, Randomized, Open-Label Phase II/III Clinical Study on the Efficacy and Safety of LB1410 Plus Lenvatinib With or Without LB4330 Versus Investigator's Choice of Chemotherapy in Advanced Recurrent/Metastatic Cervical Cancer

This is a multicenter, randomized, open-label Phase II/III clinical study, aiming to evaluate the efficacy and safety of LB1410 in combination with lenvatinib (whether in combination with LB4330）versus the chemotherapy regimen selected by the investigators for patients with advanced recurrent/metastatic cervical cancer.

Read the detailed description

This study is an open-label, multicenter Phase II/III clinical trial in advanced/metastatic cervical cancer to evaluate the antitumor efficacy, safety, tolerability, pharmacokinetics (PK), and biomarkers of LB1410 in combination with lenvatinib, with or without LB4330.

Conditions
Cervical Cancer
Being tested
LB1410, LB4330, Lenvatinib
Keywords
cervical carcinoma, LB1410, LB4330
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.

  • LB1410Biological

    LB1410 (IV, Q2W for up to 2 years)

  • LB4330Biological

    LB4330 (IV, Q2W for 4 cycles)

  • LenvatinibDrug

    lenvatinib (oral, once daily for up to 2 years)

Study groups in NCT07177716
Study groupRoleWhat they receive
Cohort 1: LB1410 + LenvatinibExperimentalLB1410 (intravenous, Q2W) with lenvatinib (oral, QD),up to 2 years
Receives: Biological: LB1410; Drug: Lenvatinib
Cohort 2: LB1410 + LB4330 + LenvatinibExperimentalLB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
Receives: Biological: LB1410; Biological: LB4330; Drug: Lenvatinib
Cohort 3: LB1410ExperimentalLB1410 (IV, Q2W for up to 2 years)
Receives: Biological: LB1410
Cohort 4: LB1410 + LB4330ExperimentalLB1410 (IV, Q2W for up to 2 years) plus LB4330 (IV, Q2W for 4 cycles)
Receives: Biological: LB1410; Biological: LB4330

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC)

    defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.

    Measured: Approximately 24 months

  2. Duration of Response (DOR) assessed by an Independent Radiology Review Committee (IRRC)

    defined as the time from the first documented response (CR or PR) to the first documented disease progression or death due to underlying cancer per RECIST 1.1.

    Measured: Approximately 24 months

Secondary outcomes (10)

  1. Objective Response Rate (ORR) assessed by the investigator

    defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.

    Measured: Approximately 24 months

  2. Duration of Response (DOR) assessed by the investigator

    defined as the time from the first documented response (CR or PR) to the first documented disease progression or death due to underlying cancer per RECIST 1.1.

    Measured: Approximately 24 months

  3. Disease Control Rate (DCR)

    defined as the percentage of evaluable patients achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 assessed by both the investigator and an Independent Radiology Review Committee (IRRC).

    Measured: Approximately 24 months

  4. Progression-Free Survival (PFS)

    defined as the time from the first dose to the first documented disease progression per RECIST 1.1 or death due to any cause (whichever occurred first) assessed by both the investigator and an IRRC.

    Measured: Approximately 24 months

  5. Overall Survival (OS)

    Overall Survival is defined as the time from the date of first study treatment to the date of death from any cause or the date of censoring.

    Measured: Until participant death/end of study,approximately 24 months

  6. Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)

    Incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events reported per NCI-CTCAE v5.0

    Measured: From the first dose administration to 30 days after the last dose

  7. ADA Antibody Positivity Rate of LB1410

    ADA Antibody Positivity Rate of LB1410

    Measured: From the first dose administration to 30 days after the last dose

  8. Pharmacokinetic (PK) parameters of LB1410-Maximum (peak) Plasma Concentration（Cmax）

    The highest concentration a drug reaches in the bloodstream after a single dose.

    Measured: From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)

  9. Pharmacokinetic (PK) parameters of LB1410-Trough Concentration（Ctrough）

    The minimum drug concentration at steady state, measured just before the next dose is administered.

    Measured: From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)

  10. Pharmacokinetic (PK) parameters of LB1410-Area Under the Curve at Steady State(AUCss)

    The total area under the plasma concentration-time curve over one dosing interval at steady state, representing total drug exposure.

    Measured: From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07177716
Sponsor's protocol ID
LB1410-CC01
Status last verified
Sep 2025
First submitted
4 Sep 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LB1410, LB4330 and Lenvatinib in people with Cervical Cancer, run by L & L Bio Co., Ltd., Ningbo, China at 1 site in China.

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 11 inclusion and 24 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Yan Luan, Doctor (86-21-54152522, luanyn2@lnlbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC) (time frame: Approximately 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07177716.

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 17 Sep 2025.

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