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

Not Applicable

Not yet recruiting

• Conditions: Cervical Cancer
• Interventions: Biological: LB1410; Drug: Lenvatinib; Biological: LB4330

• Registration Number: NCT07177716
• Lead Sponsor: L & L Bio Co., Ltd., Ningbo, China

Brief 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 cancer.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-04
• Study First Submitted QC: 2025-09-10
• Last Update Submitted: 2025-09-10
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Study Start: 2025-10-01
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: LB1410 + Lenvatinib	LB1410	LB1410 (intravenous, Q2W) with lenvatinib (oral, QD),up to 2 years
Cohort 1: LB1410 + Lenvatinib	Lenvatinib	LB1410 (intravenous, Q2W) with lenvatinib (oral, QD),up to 2 years
Cohort 2: LB1410 + LB4330 + Lenvatinib	LB1410	LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
Cohort 2: LB1410 + LB4330 + Lenvatinib	LB4330	LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
Cohort 2: LB1410 + LB4330 + Lenvatinib	Lenvatinib	LB1410 (IV, Q2W for up to 2 years), LB4330 (IV, Q2W for 4 cycles), and lenvatinib (oral, once daily for up to 2 years)
Cohort 3: LB1410	LB1410	LB1410 (IV, Q2W for up to 2 years)
Cohort 4: LB1410 + LB4330	LB1410	LB1410 (IV, Q2W for up to 2 years) plus LB4330 (IV, Q2W for 4 cycles)
Cohort 4: LB1410 + LB4330	LB4330	LB1410 (IV, Q2W for up to 2 years) plus LB4330 (IV, Q2W for 4 cycles)

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC)	Approximately 24 months	defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.
Duration of Response (DOR) assessed by an Independent Radiology Review Committee (IRRC)	Approximately 24 months	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.

Secondary Outcome Measures

Name	Time	Method
ADA Antibody Positivity Rate of LB1410	From the first dose administration to 30 days after the last dose	ADA Antibody Positivity Rate of LB1410
Objective Response Rate (ORR) assessed by the investigator	Approximately 24 months	defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.
Duration of Response (DOR) assessed by the investigator	Approximately 24 months	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.
Disease Control Rate (DCR)	Approximately 24 months	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).
Progression-Free Survival (PFS)	Approximately 24 months	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.
Overall Survival (OS)	Until participant death/end of study,approximately 24 months	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.
Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)	From the first dose administration to 30 days after the last dose	Incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events reported per NCI-CTCAE v5.0
Pharmacokinetic (PK) parameters of LB1410-Maximum (peak) Plasma Concentration（Cmax）	From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)	The highest concentration a drug reaches in the bloodstream after a single dose.
Pharmacokinetic (PK) parameters of LB1410-Trough Concentration（Ctrough）	From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)	The minimum drug concentration at steady state, measured just before the next dose is administered.
Pharmacokinetic (PK) parameters of LB1410-Area Under the Curve at Steady State(AUCss)	From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)	The total area under the plasma concentration-time curve over one dosing interval at steady state, representing total drug exposure.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, China