NCT05689853招募中1 期
An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2023年4月14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
- 87
- 试验地点
- 1
- 主要终点
- Number of subjects with dose limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with 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
- •Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations
- •Age ≥ 18 years and ≤ 75 years
- •Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
- •Measurable lesion based on RECIST v1.1
- •ECOG status of 0 or 1
- •Life expectancy ≥ 3 months
- •Adequate organ function
- •Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment
排除标准
- •Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intent
- •Currently participating in another study unless it is an observational, non-interventional clinical study or a follow-up period of an interventional study
- •Received systemic antineoplastic therapy ( e.g. chemotherapy, radiotherapy, immunotherapy) within 4 weeks prior to the first dose of investigational product; received small-molecule anticancer agents within 2 weeks prior to the first dose of investigational product
- •In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors or any other treatment directed to tumor immune mechanism
- •Prior therapy targeting CD73 or CD39 or the adenosine signalling pathway
- •Treatment with non-steroidal anti-inflammatory drugs, anti-platelet agents or anticoagulants within 7 days prior to the first dose of investigational product
- •Current dependency on systemic therapy with glucocorticoids (>10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of investigational product
- •Presence of spinal cord compression or active brain metastases
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
- •History or presence of a serious hemorrhage or known bleeding tendency within 3 months
- •Active autoimmune disease that has required systemic treatment in past 2 years
- •Clinically significant cardiovascular disease
- •History of interstitial lung disease or noninfectious pneumonitis
- •Received systemic anti-infective therapy (excluding antiviral therapy for hepatitis B or C) within 14 days prior to the first dose of investigational product
- •Major surgical procedure or serious trauma within 28 days prior to the first dose of investigational product
- •History of immunodeficiency, human immunodeficiency virus infection (HIV)
- •Active tuberculosis or syphilis infection
- •History of organ transplantation or allogeneic haematopoietic stem cell transplantation
- •Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0)
- •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
AK119 in combination with AK112
Experimental
AK119 and AK112, IV, every 3 weeks
干预措施: AK119 (Drug)
AK119 in combination with AK112
Experimental
AK119 and AK112, IV, every 3 weeks
干预措施: AK112 (Drug)
结局指标
主要结局
Number of subjects with dose limiting toxicities (DLTs)
时间窗: During the first three weeks
DLTs will be assessed during the first three 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.
Objective Response Rate (ORR)
时间窗: Up to 2 years
ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).
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.
次要结局
- Overall survival (OS)(Up to 2 years)
- Duration of response (DoR)(Up to 2 years)
- Time to response (TTR)(Up to 2 years)
- Progression free survival (PFS)(Up to 2 years)
- Time to progression (TTP)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
研究者
研究点 (1)
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