A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs)
研究概览
简要总结
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.
详细描述
This is a first-in-human (FIH), Phase 1a, multicenter, open-label, single-arm dose-escalation study of AK114 to evaluate the safety, tolerability, PK, pharmacodynamics, antitumor activity and immunogenicity in adult subjects with advanced or metastatic solid tumors. The study is comprised of dose escalation phase. Approximately 30 subjects will be treated in this 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
盲法说明
None (open Label)
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
- •Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor
- •Subject must have at least one measurable lesion according to RECIST v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1
- •At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated
- •Available archived tumor tissue sample (block or a minimum of 10 unstained slides of formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies
- •Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate
- •Adequate organ function
- •Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product
排除标准
- •History of severe hypersensitivity reactions to other monoclonal antibodies
- •History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events
- •Patients with clinically significant cardiovascular disease
- •Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration
- •Active or prior documented autoimmune disease within the past 2 years
- •History of primary immunodeficiency
- •History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications
- •Known allergy or reaction to any component of the investigational product formulation.
- •History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies.
- •Prior treatment with canakinumab.
研究组 & 干预措施
Intervention/treatment
Experimental
干预措施: AK114 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs)
时间窗: From the time of informed consent signed through to 90 days after last dose of study drug
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study drug, whether or not considered related to the study drug.
Number of participants with a Dose Limiting Toxicity (DLTs)
时间窗: Within the first 28 days after receiving the first dose of study drug
DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
次要结局
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of study drgu through to 90 days after end of treatment)
- Serum pharmacokinetics (PK)(From first dose of treatment through to 90 days after end of treatment)
- Objective response rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)