A Phase I Multi-center Study to Evaluate the Safety ,Tolerability and Efficacy of LBL-007 Combined With Toripalimab or LBL-007 Combined With Toripalimab and Axitinib Tablets in the Treatment of Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 15
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
A phase I clinical study evaluating LBL-007 in the treatment of subjects with advanced solid tumors
详细描述
This trial is a multi-center, single-arm, open-label, dose-escalation and expansion phase I study of LBL-007 combined with Toripalimab and Axitinib in the treatment of unresectable or metastatic melanoma.
It is divided into Study Part A and Study Part B. The safety, tolerability, kinetic characteristics, immunogenicity and preliminary efficacy of the subjects were evaluated. Both study part A and study part B are studied in two phases: dose escalation and dose expansion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Willingness to provide written informed consent and follow the study treatment plan and visit plan;
- •Aged ≥ 18 years at time of signing informed consent, male or female;
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1;
- •Have life expectancy of at least 12 weeks ;
- •Subject with at least one measurable tumor lesion,according to the evaluation standard of solid tumor efficacy (RECIST 1.1).
- •Exclusion criteria:
- •Subjects are allergic to LBL-007, PD-1 and similar compounds or any component in the prescription;
- •Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);
- •Have received major surgery within 4 weeks before the first administration;
- •Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);
- •Women during pregnancy or lactation;
排除标准
- 未提供
研究组 & 干预措施
LBL-007+Toripalimab+Axitinib Tablets
Study Part A： LBL-007 +Toripalimab
Study Part B： LBL-007 +Toripalimab +Axitinib Tablets
干预措施: LBL-007 (Drug)
LBL-007+Toripalimab+Axitinib Tablets
Study Part A： LBL-007 +Toripalimab
Study Part B： LBL-007 +Toripalimab +Axitinib Tablets
干预措施: Toripalimab (Drug)
LBL-007+Toripalimab+Axitinib Tablets
Study Part A： LBL-007 +Toripalimab
Study Part B： LBL-007 +Toripalimab +Axitinib Tablets
干预措施: Axitinib Tablets (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: During the first two Cycles(each cycle is 14 days)
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first two cycles.
Number of subjcects with adverse events and serious adverse events
时间窗: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy)
The safety profile of LBL-007 and Toripalimab will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0
Dose-limiting toxicities (DLT)
时间窗: During the first two Cycles(each cycle is 14 days)
DLT is defined as a toxicities(adverse event at least possibly related to LBL-007 and Toripalimab )occurring during the DLT observation period(the initial 28 days).
次要结局
- Objective Response Rate (ORR)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Disease Control Rate(DCR)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Duration of Response(DOR)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Steady state Maximum serum concentration (Cmax,ss)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Steady state Time to reach maximum serum concentration (Tmax,ss)(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Pharmacodynamic (PD) index(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Immunogenicity index(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))
- Steady state Area under the serum concentration versus time curve（AUCss）(All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (28+7 days after drug withdrawal or before the start of new anti-tumor therapy))