Recruiting
A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
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).
ClinicalTrials.gov IDNCT07281976
PhasePHASE1, PHASE2
Enrollment220
SponsorNanjing Leads Biolabs Co.,Ltd
Age18 Years and older
SexALL
Conditions studied
Triple Negative Breast Cancer
About this study
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).
Interventions
- Drug: LBL-024 for Injection — Intravenous infusion.
- Drug: albumin-bound Paclitaxel injection — Intravenous infusion.
- Drug: Toripalimab Injection — Intravenous infusion.
Primary outcomes
- Objective Response Rate (ORR) (From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
- Occurrence of adverse event (AE) and serious adverse event (SAE) (From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy))
- Progression-free Survival(PFS) (From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy))
Eligibility information
Inclusion Criteria:
1. 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.
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:
1. Use of immunomodulatory drugs within 2 weeks prior to first dose of study drug.
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.
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Study locations
- Sun Yat-sen University Cancer Center, Guangzhou, Guangdong 510062 China
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510120 China
- Harbin Medical University Cancer Hospital, Harbin, Heilongjiang 150081 China
- Henan Cancer Hospital, Zhengzhou, Henan 450000 China
- Jiangsu Province Hospital, Nanjing, Jiangsu 210029 China
- The first hospital of Jilin University, Changchun, Jilin 130021 China
- Liaoning Cancer Hospital, Shenyang, Liaoning 110000 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.