Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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