NCT07847281尚未招募1 期
A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK157D1 in the Treatment of Advanced Solid Tumors Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Akeso
- 入组人数
- 243
- 试验地点
- 3
- 主要终点
- Number of participants with dose limiting toxicities (DLTs)
研究概览
简要总结
This is an first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK157D1 for injection in advanced 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
- •Be able to understand and voluntarily sign the written informed consent form.
- •Aged of ≥ 18 years and ≤75 years.
- •Histologically-confirmed unresectable advanced solid tumors with disease progression or intolerance to standard treatment or no standard treatment available.
- •At least one measurable lesion according to RECIST v1.
- •ECOG PS 0 or
- •The expected lifespan is ≥3 months.
- •Have sufficient organ function.
- •Females participants 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
- •Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included.
- •Having other active malignancies within 3 years.
- •Having received major surgical operations within 4 weeks before the first administration.
- •Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
- •Participants with a history of mental illness and incapacitated or limited capacity.
- •Having received systemic anti-tumor treatment within 3 weeks.
- •Having received any treatment targeting B7H
- •Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
- •Previous history of severe hypersensitivity reactions.
- •Participants with active autoimmune diseases requiring systemic treatment within 2 years.
- •Known to be positive for HIV and other infections.
- •Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first dose.
- •Live attenuated vaccines were received within 4 weeks.
- •Currently participating in another interventional clinical study.
- •Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
研究组 & 干预措施
AK157D1 for injection
Experimental
AK157D1 for injection will be administered in prespecified dose levels
干预措施: AK157D1 for injection (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities (DLTs)
时间窗: During the first 3 weeks of treatment.
DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug.
Number of participants with adverse events (AEs)
时间窗: From the time of signing informed consent form through 30 days(for AEs) or 90 days(for SAEs) after the last dose of study drug.
AEs refer to any untoward medical occurrence or deterioration of existing medical events after the participants sign the ICFs, whether or not considered related to the study treatment.
次要结局
- Area under curve (AUC)(From pre-dose to the end of the last dose, an average of 6 months.)
- Maximum Concentration (Cmax)(From pre-dose to the end of the last dose, an average of 6 months.)
- Peak Time (Tmax)(From pre-dose to the end of the last dose, an average of 6 months.)
- The terminal elimination half-life (t1/2)(From pre-dose to the end of the last dose, an average of 6 months.)
- Clearance (CL)(From pre-dose to the end of the last dose, an average of 6 months.)
- Volume of distribution (V)(From pre-dose to the end of the last dose, an average of 6 months.)
- Anti-drug antibodies (ADA)(From pre-dose to 30 days post end of treatment)
- Objective Response Rate (ORR) assessed by investigator per RECIST v1.1(Up to approximately 2 years)
- Disease Control Rate (DCR) assessed per RECIST v1.1(Up to approximately 2 years)
- Duration of response (DoR) assessed by the investigator per RECIST v1.1(Up to approximately 2 years)
- Time to response (TTR) assessed by the investigator per RECIST v1.1(Up to approximately 2 years)
- Progression Free Survival (PFS) assessed by investigator per RECIST v1.1(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
研究者
研究点 (3)
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