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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 7
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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~
- •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.
排除标准
- •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.
研究组 & 干预措施
LBL-024 + albumin-bound paclitaxel
Experimental group：
LBL-024 + albumin-bound paclitaxel.
Intravenous infusion.
干预措施: LBL-024 for Injection (Drug)
LBL-024 + albumin-bound paclitaxel
Experimental group：
LBL-024 + albumin-bound paclitaxel.
Intravenous infusion.
干预措施: albumin-bound Paclitaxel injection (Drug)
Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel
control group：
Toripalimab + albumin-bound paclitaxel or albumin-bound paclitaxel.
Intravenous infusion.
干预措施: albumin-bound Paclitaxel injection (Drug)
Toripalimab + albumin-bound paclitaxel/albumin-bound paclitaxel
control group：
Toripalimab + albumin-bound paclitaxel or albumin-bound paclitaxel.
Intravenous infusion.
干预措施: Toripalimab Injection (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Cmax(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))
- Tmax(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))
- Immunogenicity(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))
- Disease Control Rate(DCR)(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))
- Duration of Response(DOR)(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))