A Phase I, Multi-center, Open-label Study With Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Adverse events
研究概览
简要总结
A Phase I, Multi-center, Open-label Study with Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects with Advanced Solid Tumors
详细描述
Dose escalation This part is meant to evaluate the safety, tolerability, PK, immunogenicity, preliminary antitumor activity, the MTD and RP2D of JYB1907 in patients with histologically or cytologically confirmed advanced solid tumors.
Expansion cohort The antitumor activity, safety, tolerability, PK and immunogenicity of JYB1907 will be further evaluated in other cohorts.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent voluntarily;
- •Age ≥18, male or female;
- •Have at least one evaluable lesion (Dose escalation) or measurable lesion;
- •Expected survival ≥12 weeks；
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
排除标准
- •Received within 4 weeks before the initial treatment, or scheduled during the study to receive a major surgery, live attenuated vaccines, or any anti-tumor therapy.
- •With severe tumor complications.
- •Pregnant or lactating women, or positive serum pregnancy test;
- •Concurrent participation in another interventional study；
- •With other diseases or clinical abnormalities assessed by the Investigator as ineligible.
研究组 & 干预措施
JYB1907 Dose 1
Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.
The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.
干预措施: JYB1907 (Drug)
JYB1907 Dose 2
Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.
The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.
干预措施: JYB1907 (Drug)
JYB1907 Dose 3
Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.
The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.
干预措施: JYB1907 (Drug)
JYB1907 Dose 4
Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.
The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.
干预措施: JYB1907 (Drug)
JYB1907 Dose 5
Five dose levels of JYB1907 are evaluated in the dose escalation part.In the expansion cohort part, the biologically active dose(s) confirmed in the dose escalation part with one or more dosing regimens will be selected.
The dose of JYB1907 is based on the actual body weight as measured prior to each intravenous administration.
干预措施: JYB1907 (Drug)
结局指标
主要结局
Adverse events
时间窗: until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first.
Adverse events, and changes from baseline in vital signs,etc.
次要结局
- Serum concentrations of Immunogenicity Analysis(until 28 days after last dose of study drug)
- Serum concentrations of JYB1907(until 28 days after last dose of study drug)
- Serum concentrations of Preliminary antitumor activity(until 28 days after last dose of study drug)