An Open-label, Multi-center Phase Ib/II Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection ± Bevacizumab in Patients With Platinum-resistant Ovarian Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 17
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is an open-label, multicenter Phase Ib/II clinical trial of LBL-024 in combination with other drugs for the treatment of patients with platinum-resistant ovarian cancer (OC), aiming to evaluate the efficacy and safety of LBL-024 in combination with other drugs in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC).
详细描述
The trial consists of two phases: Phase Ib and Phase II.
Phase Ib is a single arm, open label, safety and efficacy exploration phase, which includes two cohorts with different dosing regimens. The two cohorts can be conducted simultaneously. After completion of Phase Ib, the sponsor and investigators will jointly evaluate the safety, tolerance and preliminary efficacy of combination treatment. Based on this evaluation, they will decide to continue Phase II study with the current protocol or adjust the design of Phase II study before initiating the study.
Phase II is an open-label, randomized, positive-controlled extension study in which eligible participants were randomly assigned to the trial group or control group at a ratio of 2:1.
This study plans toenroll up to 180 subjects.
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 Participants 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 include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
排除标准
- •The Participants is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.
- •Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
- •Participants with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.
- •Participants with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
- •The Participants has a Medical history of immunodeficiency, including HIV antibody positive.
- •Active hepatitis B or active hepatitis C.
- •Women during pregnancy or lactation.
- •History of mental and/or psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
- •The investigator believes that the Participants 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 + Paclitaxel injection + bevacizumab
LBL-024 + Paclitaxel injection + bevacizumab.
Intravenous infusion.
干预措施: Paclitaxel injection (Drug)
LBL-024 + Paclitaxel injection
LBL-024 + Paclitaxel injection.
Intravenous infusion.
干预措施: LBL-024 for Injection (Drug)
LBL-024 + Paclitaxel injection + bevacizumab
LBL-024 + Paclitaxel injection + bevacizumab.
Intravenous infusion.
干预措施: LBL-024 for Injection (Drug)
LBL-024 in Combination With paclitaxel ± bevacizumab
LBL-024 in Combination With paclitaxel ± bevacizumab.
Intravenous infusion.
干预措施: LBL-024 for Injection (Drug)
Paclitaxel ± bevacizumab
Paclitaxel ± bevacizumab.
Intravenous infusion.
干预措施: Bevacizumab injection (Drug)
LBL-024 in Combination With paclitaxel ± bevacizumab
LBL-024 in Combination With paclitaxel ± bevacizumab.
Intravenous infusion.
干预措施: Paclitaxel injection (Drug)
LBL-024 in Combination With paclitaxel ± bevacizumab
LBL-024 in Combination With paclitaxel ± bevacizumab.
Intravenous infusion.
干预措施: Bevacizumab injection (Drug)
LBL-024 + Paclitaxel injection
LBL-024 + Paclitaxel injection.
Intravenous infusion.
干预措施: Paclitaxel injection (Drug)
LBL-024 + Paclitaxel injection + bevacizumab
LBL-024 + Paclitaxel injection + bevacizumab.
Intravenous infusion.
干预措施: Bevacizumab injection (Drug)
Paclitaxel ± bevacizumab
Paclitaxel ± bevacizumab.
Intravenous infusion.
干预措施: Paclitaxel 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.
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.
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 in combination with paclitaxel 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))