An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 369
- 试验地点
- 10
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC patients.
详细描述
This study included phase Ib (safety introduction period) and phase II (randomized controlled extension period).
Phase Ib and Phase II each contain two independent cohorts, Cohort 1 and Cohort 2.
After comprehensive evaluation by the sponsor and investigator, the safety and tolerability of combination therapy in Phase Ib Cohort 1 and Cohort 2 were good, and preliminary efficacy was observed,Participants will be enrolled to conduct the two cohorts of phase II study.The Phase II study design will be adjusted based on results from the Phase Ib study.The population enrolled in Cohort 1 of Phase II will be determined by the results of Cohort 1A and Cohort 1B of Phase Ib.In Cohort 2 of Phase II, eligible participants were randomly assigned to the B1 group and B2 group in a 2: 1 ratio.
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 75 Years（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.
- •Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
- •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.
- •There is adequate organ and bone marrow function,Conforms to laboratory test results.
- •Male of childbearing potential and 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.
排除标准
- •Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
- •Women during pregnancy or lactation.
- •Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction.
- •participant had a history of severe cardiovascular and cerebrovascular disorder.
- •Subjects who received a live vaccine within 4 weeks prior to the first dose or are scheduled to receive a live vaccine during the study treatment period and within 4 weeks after the last dose.
- •patients with active,Or patients who have had and may recur autoimmune diseases.
- •patients with active hepatitis B or active hepatitis C.
- •History of immunodeficiency including HIV antibody test positive.
- •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 + bevacizumab
LBL-024 + bevacizumab.
Intravenous infusion.
干预措施: LBL-024 for Injection (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: LBL-024 for Injection (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: Bevacizumab injection (Drug)
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy.
Intravenous infusion or Oral .
干预措施: LBL-024 for Injection (Drug)
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy.
Intravenous infusion or Oral .
干预措施: Fruquintinib Capsules (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: LBL-024 for Injection (Drug)
LBL-024 + bevacizumab
LBL-024 + bevacizumab.
Intravenous infusion.
干预措施: Bevacizumab injection (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: Oxaliplatin injection (Drug)
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy
LBL-024 + bevacizumab/LBL-024 monotherapy/fruquintinib monotherapy.
Intravenous infusion or Oral .
干预措施: Bevacizumab injection (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: Oxaliplatin injection (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: Capecitabine tablets (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: Capecitabine tablets (Drug)
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine
LBL-024 + bevacizumab + oxaliplatin + capecitabine/ bevacizumab + oxaliplatin + capecitabine.
Intravenous infusion and Oral .
干预措施: Bevacizumab 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).
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 Combination Therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.
次要结局
- 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))
- 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))
- Overall survival (OS)(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))
- 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))