A Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AK138D1 in Advanced Solid Tumors
概览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Akeso
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
概览
简要总结
This is a Phase I clinical trial testing the safety and effectiveness of AK138D1in patients with advanced cancer. The study will enroll up to 200 patients with various types of advanced solid tumors who haven't responded to standard treatments. Patients will receive AK138D1 to determine the safest dose and evaluate if the drug can help treat their cancer.
详细描述
This open-label, dose-escalation and expansion Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of AK138D1 in subjects with advanced malignant tumors. The study will test different doses of AK138D1 to find the recommended dose for future studies and assess whether the drug shows signs of effectiveness against cancer. Participants will receive AK138D1 through intravenous infusion and will be closely monitored for side effects and treatment response. The final number of participants enrolled will depend on the safety and effectiveness results observed during the study.
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
- 否
入选标准
- •The subject must sign the written informed consent form (ICF) voluntarily;
- •At enrollment, aged ≥ 18 to ≤ 75 years, both males and females are eligible;
- •ECOG performance status score of 0 or 1;
- •Has a life expectancy of ≥ 3 months;
- •At least 1 measurable lesion as per RECIST v1.1 that is suitable for repeated accurate measurement.
- •Adequate organ function.
排除标准
- •Prior human epidermal growth factor receptor 3 (HER3) -targeted therapies, including antibodies, antibody-drug conjugates (ADCs), chimeric antigen receptor T-cell immunotherapy (CAR-T), and others;
- •Concomitant participation in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study;
- •Presence of active central nervous system (CNS) metastases.
- •Live vaccines or attenuated live vaccines administered within 4 weeks prior to the first dose, or planned to be administered during the study; use of inactivated vaccines is allowed;
- •Untreated subjects with active hepatitis B or active hepatitis C;
- •Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
- •Known active syphilis infection;
- •Subjects with known allergy to any component of any study drug; and with a history of known severe hypersensitivity reactions to other monoclonal antibodies;
- •Other reasons for ineligibility as evaluated by the investigator.
研究组 & 干预措施
AK138D1
AK138D1 will be administered in pre-specified dose levels.
干预措施: AK138D1 (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Up to approximately 2 years
Incidence and severity of participants with adverse events
Dose-Limiting Toxicity (DLT)
时间窗: Up to approximately 2 years
Occurrence of DLTs and determination fo maximum tolerated dose (MTD)
次要结局
- Peak Plasma Concentration (Cmax) of AK138D1(Up to approximately 2 years)
- Area under the plasma concentration versus time curve (AUC) of AK138D1(Up to approximately 2 years)
- Anti-drug antibodies (ADA)(Up to approximately 2 years)
- Objective Response Rate (ORR) assessed by investigator per RECIST v1.1(Up to approximately 2 years)
- Disease Control Rate (DCR) assessed by investigator 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)
- Progression Free Survival (PFS) assessed by 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)
- Overall Survival (OS)(Up to approximately 2 years)