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
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
Inclusion Criteria6
- Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- At the time of signing the informed consent form, the age was ≥ 18 years old.
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
- 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 Criteria10
- Use of immunomodulatory drugs within 2 weeks prior to first dose of study drug.
- 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.
- Patients with clinically uncontrolled pleural effusion, peritoneal effusion, or pericardial effusion.
- Active infection within 2 weeks prior to first dose of study drug.
- Active infectious disease.
- Women with plans for pregnancy,Or women who are pregnant or breastfeeding.
- Active hepatitis B or active hepatitis C.
- History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
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Interventions
DRUGLBL-024 for Injection
Intravenous infusion.
DRUGalbumin-bound Paclitaxel injection
Intravenous infusion.
DRUGToripalimab Injection
Intravenous infusion.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07281976