A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
NCT ID: NCT07281976
Last Updated: 2026-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2026-01-27
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBL-024 + albumin-bound paclitaxel
Experimental group：
LBL-024 + albumin-bound paclitaxel.
Intravenous infusion.
LBL-024 for Injection
Intravenous infusion.
albumin-bound Paclitaxel injection
Intravenous infusion.
Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel
control group：
Toripalimab + albumin-bound paclitaxel or albumin-bound paclitaxel.
Intravenous infusion.
albumin-bound Paclitaxel injection
Intravenous infusion.
Toripalimab Injection
Intravenous infusion.
Interventions
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LBL-024 for Injection
Intravenous infusion.
albumin-bound Paclitaxel injection
Intravenous infusion.
Toripalimab Injection
Intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At the time of signing the informed consent form, the age was ≥ 18 years old.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
6. Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug; Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.Male patients are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug,and do not donate sperm during this period.
Exclusion Criteria
2. Patients who received live vaccination within 4 weeks before the first dose of study drug or who are scheduled to receive live vaccination during the study treatment period and within 4 weeks after the last dose.
3. Patients with clinically uncontrolled pleural effusion, peritoneal effusion, or pericardial effusion.
4. Active infection within 2 weeks prior to first dose of study drug.
5. Active infectious disease.
6. Women with plans for pregnancy,Or women who are pregnant or breastfeeding.
7. Active hepatitis B or active hepatitis C.
8. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
\-
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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yongmei Yin
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBL-024-CN005
Identifier Type: -
Identifier Source: org_study_id
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