NCT06691360尚未招募1 期
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK137 (Bispecific Antibody Targeting CD73 and LAG-3) in Patients With Advanced Malignant Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2024年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- AEs
研究概览
简要总结
A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of AK137 in patients with advanced malignant 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
- 否
入选标准
- •Written and signed informed consent.
- •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or
- •Life expectancy ≥3 months.
- •Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
- •Subject must have at least one measurable lesion according to RECIST Version1.
- •Adequate organ function.
排除标准
- •Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
- •Receipt of any anti-CD73, anti-LAG-3 treatment.
- •Experienced a toxicity that led to the permanent discontinuation of prior immunotherapy. All adverse events (AEs) while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening. Additionally, the use of immunosuppression other than corticosteroids was required.
- •Unresolved toxicities from prior anticancer therapy, defined as not having resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels specified in the inclusion/exclusion criteria, except for toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
- •Major surgical procedure within 4 weeks prior to the first dose of AK137 or still recovering from prior surgery.
- •History of organ transplant.
- •Known allergy or reaction to any component of the AK137 formulation. History of severe hypersensitivity reactions to other mAbs.
研究组 & 干预措施
AK137
Experimental
Each subject will receive a single dose of AK137 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met.
干预措施: AK137 (Drug)
结局指标
主要结局
AEs
时间窗: From time ICF is signed until 90 days after last dose of AK137
Incidence and severity of participants with adverse events
DLT
时间窗: During the first 28-day of treatment with AK137
次要结局
- Objective Response Rate (ORR)(Up to approximately 2 years)
- Disease Control Rate (DCR)(Up to approximately 2 years)
- Duration of Response (DoR)(Up to approximately 2 years)
- Time to response (TTR)(Up to approximately 2 years)
- Progression Free Survival (PFS)(Up to approximately 2 years)
- Overall Survival (OS)(Up to approximately 2 years)
- Cmax of AK137(From first dose of study drug through end of treatment (up to approximately 2 years))
- Cmin of AK137(From first dose of study drug through end of treatment (up to approximately 2 years))
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of study drug through 30 days after last dose of study drug)
研究者
研究点 (1)
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