A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
Recruiting · NCT07281976 · Interventional (participants receive a specific treatment) · Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
View the official record on ClinicalTrials.gov →Interventions studied
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
7 locations listed.
- 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