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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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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Primary outcome measure(s)
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) According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.
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) Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 or LBL-024 Combination Administration will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
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) According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.
Trial sites (7)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Jiangsu Province Hospital
Nanjing
Jiangsu
Recruiting
The first hospital of Jilin University
Changchun
Jilin
Recruiting
Liaoning Cancer Hospital
Shenyang
Liaoning
Recruiting
More Nanjing Leads Biolabs Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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