A Phase 1, Multi-Center, Open-Label Dose Escalation Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6026 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- dose-limiting toxicity (DLT)
研究概览
简要总结
the main purpose:
- Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability
- Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules.
Secondary purpose:
- Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug;
- Evaluate the immunogenicity of BAT6026 injection;
- Evaluate the pharmacodynamic properties of BAT6026 injection;
- Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.
详细描述
This study is designed as a phase I clinical trial of multi-center, open, dose escalation, and extended research.
The study mainly evaluates the safety, tolerability and PK characteristics of BAT6026 injection in patients with advanced malignant solid tumors, explores the maximum tolerated dose and preliminary anti-tumor efficacy, and provides a basis for the recommended dose of subsequent clinical trials.
The research is divided into 2 phases:
The first stage: dose escalation study. The safety, tolerability and pharmacokinetic characteristics of BAT6026 were explored using rapid titration and the "3+3" dose escalation rule.
Because the clinical efficacy benefit of a single drug may be limited, from the ethical point of view of exposing fewer subjects to invalid doses, this dose escalation study uses rapid titration and the "3+3" dose escalation rule to explore the safe dose range . A total of 7 (or 8) dose groups are set up, namely the 0.01 mg/kg group, 0.03mg/kg group, 0.1mg/kg group, 0.3mg/kg group, 1mg/kg group, 3mg/kg group, 6mg/kg Group and 10mg/kg group (optional). Among them, the 0.01mg/kg group and the 0.03mg/kg group use accelerated titration Method to increase the dose; 0.1mg/kg group, 0.3mg/kg group, 1mg/kg group, 3mg/kg group, The 6mg/kg group and the 10mg/kg group were studied in dose escalation according to the standard "3+3" rule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Age: ≥18 years of age ≤75 years of age, gender: men and women are not limited;
- •The investigator estimates that the expected survival period is at least 3 months;
- •The Eastern Cooperative Oncology Group (ECOG) performance status scoring requirement is 0 or 1;
- •Patients with locally advanced or metastatic solid tumors diagnosed by pathology who have failed standard treatment or have no effective treatment methods (refer to CSCO guidelines in 2021);
- •According to the tumor efficacy evaluation standard RECIST 1.1, there must be at least one measurable tumor lesion during the dose expansion stage;
排除标准
- •Have received anti-OX40 monoclonal antibody or double-antibody drug therapy with anti-OX40 activity in the past;
- •It is receiving or expected to receive other anti-tumor treatments during the first study drug administration, including but not limited to chemotherapy, radiotherapy, immunotherapy, hormone therapy (except alternative therapies), targeted therapy, biological therapy, and anti-tumor effects Chinese patent medicine, etc.;
- •Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time, except for the following items:? Nitrosourea or Mitomycin C is within 6 weeks before the first use of the study drug;? Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or 5 half-lives of the drug (whichever is longer);? Chinese medicine with anti-tumor indications should be within 2 weeks before the first use of the study drug;
- •Clinical investigators who are participating in this study or who have participated in experimental drugs or medical devices within 4 weeks before the first administration of this study cannot be included;
- •Have been vaccinated within 4 weeks before the first administration or plan to vaccinate live/attenuated vaccines and mRNA vaccines during the study period;
- •Pregnant or lactating women;
- •Patients whose AEs caused by the original anti-tumor therapy within 4 weeks before the first administration of the study drug did not return to CTCAE 5.0≤1 (except for hair loss and fatigue ≤2); previous irAE ≥3 or any level of irAE Those who have terminated immunotherapy;
- •Major surgery (defined as grade 3 and 4 surgery) within 4 weeks before the first administration;
- •Those who have a history of tissue or organ transplantation;
- •Subjects who have had serious infections within 4 weeks before the first administration, including but not limited to infectious complications that require hospitalization, bacteremia, severe pneumonia, etc.; subjects with active infections before the first administration are excluded By;
研究组 & 干预措施
BAT6026 0.01mg/kg
BAT6026 0.01mg/kg,intervenous infusion,sample size 1
干预措施: BAT6026 (Drug)
BAT6026 0.03mg/kg
BAT6026 0.03mg/kg,intervenous infusion,sample size 1
干预措施: BAT6026 (Drug)
BAT6026 0.1mg/kg
BAT6026 0.1mg/kg,intervenous infusion,sample size 3~6
干预措施: BAT6026 (Drug)
BAT6026 0.3mg/kg
BAT6026 0.3mg/kg,intervenous infusion,sample size 3~6
干预措施: BAT6026 (Drug)
BAT6026 1mg/kg
BAT6026 1mg/kg,intervenous infusion,sample size 3~6
干预措施: BAT6026 (Drug)
BAT6026 3mg/kg
BAT6026 3mg/kg,intervenous infusion,sample size 3~6
干预措施: BAT6026 (Drug)
BAT6026 6mg/kg
BAT6026 6mg/kg,intervenous infusion,sample size 3~6
干预措施: BAT6026 (Drug)
Amplification group
BAT6026 10mg/kg,intervenous infusion,sample size 3~6
干预措施: BAT6026 (Drug)
结局指标
主要结局
dose-limiting toxicity (DLT)
时间窗: 3 weeks
safety and tolerability endpoint
maximum tolerated dose (MTD)
时间窗: 3 weeks
maximum tolerated dose (MTD)
次要结局
- Maximum serum drug concentration（Cmax)(no more than 52 weeks)