NCT06166888招募中1 期
A Phase Ia/Ib, Multicenter and Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Anti-PD-1 and CD73 Bispecific Antibody AK131 in Patients With Advanced Solid Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年1月10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
- 130
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events (AEs)
研究概览
简要总结
This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients
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 —（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.
- •Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.
排除标准
- •Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers.
- •Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
- •Receipt of any anti-CD73 treatment.
- •Anticancer therapy within 4 weeks prior to the first dose of investigational product.
- •Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
- •Subjects with spinal cord compression or active brain metastases, except for subjects with untreated and asymptomatic brain metastases or with stable brain metastases after treatment.
- •Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Subjects whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the study.
- •Toxicities of prior anticancer therapy have not resolved to ≤ Grade
- •Patients with clinically significant cardio-cerebrovascular disease.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •History of interstitial lung disease or noninfectious pneumonitis.
- •Major surgery, trauma,unhealed wound, ulcer or fracture within 4 weeks prior to first dose of investigational product.
- •Any condition that required systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of investigational product.
- •Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
- •Known allergy or reaction to any component of the AK131 formulation.
- •Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
研究组 & 干预措施
AK131
Experimental
Subjects will receive AK131 via intravenously (IV) Q2W or Q3W, up to 2 years
干预措施: AK131 (Drug)
结局指标
主要结局
Number of subjects with adverse events (AEs)
时间窗: From the time of informed consent signed through 90 days after the last dose of study drug
AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Number of subjects with dose limiting toxicities (DLTs)
时间窗: During the first 4 weeks
DLTs will be assessed during the first 4 weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.
次要结局
- 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)
- Time to response (TTR)(Up to approximately 2 years)
- Serum PK concentration of AK131(From first dose of study drug through 30 days after last dose of study drug)
- 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)
- Overall survival (OS)(Up to approximately 2 years)
- Progression-free survival (PFS)(Up to approximately 2 years)
研究者
研究点 (1)
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