NCT07042802

A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

An Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection in Patients With Platinum-resistant Ovarian Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, multicenter phase Ib/II clinical study of LBL-024 combination therapy in patients with platinum-resistant ovarian cancer (OC),To evaluate the efficacy and safety of LBL-024 combination therapy in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC) patients.

Detailed description

The trial was divided into two phases. Stage I (Phase Ib): Single-Arm Safety Lead-In Period. In this stage, a small number of subjects were enrolled first and received LBL-024 combined with paclitaxel treatment, with 21 days as a cycle.Safety, tolerability and preliminary efficacy of combination drugs were assessed by the sponsor and investigators.LBL-024 Dose De-escalation Principle Based on Safety and Tolerability. Stage II (Phase II) Randomized, Expansion Cohort Study. If safety and tolerability are good, the combined administration extension study will be continued. Subjects were continued to be enrolled in the study. The study was designed as a randomized, open-label, positive-controlled trial.Subjects who met the criteria were randomly assigned to the experimental group and the control group in a ratio of 2: 1.Experimental group (LBL-024 combined with paclitaxel) and Control group (paclitaxel monotherapy). This study will enroll up to 110 subjects.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	LBL-024 for Injection	LBL-024 Intravenous infusion.
DRUG	Paclitaxel Injection	Paclitaxel Intravenous infusion.

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-12-25
• Completion: 2028-12-25
• First posted: 2025-06-29
• Last updated: 2026-03-06

Locations

13 sites across 1 country: China