Overview
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).
Description
The trial was divided into two phases.
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.
Eligibility
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.
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