RecruitingPhase 1Phase 2NCT07281976

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


Sponsor

Nanjing Leads Biolabs Co.,Ltd

Enrollment

220 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called LBL-024 — either alone or in combination with other medications — for people with triple-negative breast cancer (a type of breast cancer that does not respond to hormone therapies). **You may be eligible if...** - You are 18 or older - You have been diagnosed with triple-negative breast cancer - You have at least one tumor that can be measured on imaging scans - Your general health and ability to function is rated as good (ECOG score 0–1) - Your expected survival is at least 12 weeks - If you can become pregnant, you agree to use highly effective contraception from consent through 6 months after the last dose **You may NOT be eligible if...** - You do not have measurable disease - You have significant organ dysfunction - You are pregnant or unwilling to use contraception - You do not meet the health requirements set out in the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLBL-024 for Injection

Intravenous infusion.

DRUGalbumin-bound Paclitaxel injection

Intravenous infusion.

DRUGToripalimab Injection

Intravenous infusion.


Locations(7)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The first hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07281976


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