NCT07281976

A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer

An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 Monotherapy or in Combination With Albumin-bound Paclitaxel in Patients With Recurrent or Metastatic Triple Negative Breast Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (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 to evaluate the efficacy and safety of LBL-024 monotherapy or in combination with albumin-bound paclitaxel in patients with recurrent or metastatic triple negative breast cancer(TNBC).

Detailed description

The trial was divided into two phases. Stage I (Phase Ib): Part A: Monotherapy Period:In the phase Ib Part A monotherapy period, a small number of TNBC patients were planned to be enrolled to receive LBL-024 monotherapy.The safety, tolerability, and preliminary efficacy of LBL-024 monotherapy in this population will be assessed by the sponsor and investigator in combination. Part B: Combination Drug Safety Run-In Period:If the safety and tolerability are good and there is preliminary efficacy in Part A,The investigator discussed with the sponsor to decide whether to continue the study in Part B of Phase Ib.Part B is designed to enroll a small number of TNBC patients to receive LBL-024 combination therapy. Stage II (Phase II) ： If the safety and tolerability are good and there is preliminary efficacy in the first stage,The investigator discusses with the sponsor to decide whether to continue the co-administration expansion study, continue to enroll TNBC patients, and using a randomized, open, positive control trial design. This study will enroll up to 220 subjects.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	LBL-024 for Injection	Intravenous infusion.
DRUG	albumin-bound Paclitaxel injection	Intravenous infusion.
DRUG	Toripalimab Injection	Intravenous infusion.

Timeline

• Start date: 2026-01-27
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-12-15
• Last updated: 2026-02-12

Locations

7 sites across 1 country: China