NCT06730386招募中1 期
A First-in-human, Phase I Study of Evaluating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AK138D1 in the Treatment of Advanced Solid Tumors
Akeso4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- AEs
研究概览
简要总结
This is an open-label, first-in-human, Phase I clinical study aimed at evaluating the safety, tolerability, PK, immunogenicity, and preliminary antitumor efficacy of AK138D1 in subjects being treated for advanced solid tumors.
详细描述
This study is comprised of two parts: the dose-escalation and dose-expansion stages. Dose-escalation stage aims to determine the MTD/MAD, while the dose-expansion stage is designed to establish the RP2D.
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;
- •Subjects who have histologically or cytologically diagnosed locally advanced or metastatic solid tumor, which Is refractory to or intolerant to standard treatment;
- •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.
- •Patients with a history of non-infectious pneumonitis requiring systemic corticosteroid therapy; a history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis); currently suffering from ILD/pneumonitis or suspected of having such diseases based on imaging during screening;
- •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 (HBsAg positive and HBV-DNA exceeding 1000 copies/mL (200 IU/mL) and above the lower limit of detection). For HBsAg-positive subjects, anti-hepatitis B therapy is required during the study; subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection) is also an exclusion;
- •Known active pulmonary tuberculosis (TB); subjects with suspected active TB must undergo appropriate clinical assessment to rule out the presence of active disease;
- •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
Experimental
AK138D1 will be administered in pre-specified dose levels.
干预措施: AK138D1 (Drug)
结局指标
主要结局
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
- Cmax and Cmin 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)
- 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 (4)
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