Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT07281976

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

Led by Nanjing Leads Biolabs Co.,Ltd · Updated on 2026-02-12

220

Participants Needed

7

Research Sites

100 weeks

Total Duration

On this page

Sponsors

N

Nanjing Leads Biolabs Co.,Ltd

Lead Sponsor

T

The First Affiliated Hospital with Nanjing Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Agree to follow the trial treatment plan, visit schedule, lab tests, and other protocol requirements and voluntarily sign informed consent
  • Age 18 years or older at the time of consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Expected survival time of at least 12 weeks
  • At least one measurable tumor lesion based on RECIST 1.1 criteria
  • Female participants of childbearing age willing to use effective contraception during the study and for 6 months after last drug dose; negative pregnancy test within 7 days before first dose
  • Male participants willing to use effective contraception during the study and for 6 months after last drug dose and not donate sperm during this time
Not Eligible

You will not qualify if you...

  • Use of immunomodulatory drugs within 2 weeks before first study drug dose
  • Receipt of live vaccines within 4 weeks before first study drug dose or planned during treatment and for 4 weeks after last dose
  • Clinically uncontrolled pleural, peritoneal, or pericardial effusion
  • Active infection within 2 weeks before first study drug dose
  • Active infectious disease
  • Women who are pregnant, breastfeeding, or planning pregnancy
  • Active hepatitis B or C infection
  • History of mental illness affecting consent, drug abuse, alcoholism, or drug addiction
  • Any condition that may affect compliance or suitability for participation, as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 7 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510062

Actively Recruiting

2

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

Guangzhou, Guangdong, China, 510120

Actively Recruiting

3

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150081

Actively Recruiting

4

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Actively Recruiting

5

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

6

The first hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

7

Liaoning Cancer Hospital

Shenyang, Liaoning, China, 110000

Actively Recruiting

Loading map...

Research Team

Y

yongmei Yin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here