NCT07617493招募中1 期
An Open, Multicenter, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of ICP-B208 in Participants of Advanced Solid Tumor Trials
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 539
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of ICP-B208 in the trial participants of unresectable advanced or metastatic solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •18 years old to 75 years old;
- •Unresectable locally advanced or metastatic gastrointestinal tumors or other advanced solid tumors that have failed previous systemic treatment and have been confirmed by histopathology or cytology;
- •The ECOG physical fitness score is 0 to 1 point.
- •There is at least one measurable lesion;
- •The organ function level must meet the prescribed standards;
- •Effective contraceptive measures should be taken from the date of signing the informed consent form until at least 6 months after the use of the last dose of the study drug.
- •Voluntarily enroll in the group and sign the informed consent form, and follow the trial treatment protocol and visit plan.
排除标准
- •Other active malignant tumors occurred within 3 years before the first administration of the study drug;
- •Received the anti-tumor treatment defined by the protocol within the time range before the first administration of the study drug specified in the protocol;
- •Trial participants with unstable primary CNS tumors or CNS metastases;
- •Uncontrollable or significant major cardiovascular diseases;
- •Severe or uncontrollable systemic diseases; Or any unstable systemic disease;
- •Active infection as defined in the plan;
- •Have a history of severe allergic reactions to active pharmaceutical ingredients, non-active components in drugs or antibody drugs;
- •Those who are known to have a history of alcohol abuse or drug abuse;
- •Other circumstances that the researcher deems unsuitable for participation in this study.
研究组 & 干预措施
ICP-B208
Experimental
干预措施: ICP-B208 (Drug)
研究者
研究点 (1)
Loading locations...
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