NCT07566247尚未招募1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor
Akeso3 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年4月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 3
研究概览
简要总结
This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to understand and voluntarily sign the written informed consent form.
- •Aged of ≥ 18 years and ≤75 years.
- •ECOG PS 0 or
- •The expected lifespan is ≥3 months.
- •Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
- •At least one measurable lesion according to RECIST v1.
- •Adequate organ function.
- •Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception
排除标准
- •Having other active malignancies within 3 years.
- •Currently participating in another interventional clinical study.
- •Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- •Having received any treatment targeting CSF-1R, ILT2 and ILT4..
- •Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.
- •Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
- •Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
- •Participants with active autoimmune diseases requiring systemic treatment within 2 years.
- •Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period.
- •Known to be positive for HIV and other infections.
- •Live attenuated vaccines were received within 28 days.
- •13. Participants with a history of mental illness and incapacitated or limited capacity.
- •14. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
研究者
研究点 (3)
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