NCT04547205已完成1 期
A Phase I, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of AK109，an Anti-VEGFR2 Monoclonal Antibody in Subjects With Advanced Solid Tumors
Akeso1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年6月6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
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a first in human(FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity and anti-tumor activity of AK109, an anti-VEGFR2 monoclonal antibody, as a single agent in adult subjects with advanced solid tumor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed written informed consent form voluntarily.
- •Histologically or cytologically documented advanced solid tumor that is refractory/relapsed/intolerant to standard therapies, or for which no effective standard therapy is available, or subject refuses standard therapy.
- •Have radiologically measurable disease based on RECIST 1.1
- •ECOG of 0 or
- •Estimated life expectancy of ≥3 months.
- •Adequate organ function.
- •Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
排除标准
- •have been diagnosed other advanced tumors within 2 years before the first use of the study drug, except for the cured localized tumors.
- •with active central nervous system metastasis, cancerous meningitis, or spinal cord compression.
- •Prior use of any anti-VEGF or anti-VEGFR antibodies.
- •Receipt of anti-tumor treatment, other study drug, major surgery, or serious infection within 4 weeks prior to C1D1 (Cycle 1 Day1, the first dose of study drug).
- •Have received central venous catheterization within 7 days prior to C1D
- •Severe or uncontrolled cardiovascular and cerebrovascular diseases.
- •Uncontrolled hypertension.
- •have a high risk of bleeding.
- •Uncontrolled gastrointestinal diseases.
- •Uncontrolled pleural/pericardial or peritoneal effusion.
- •Have occurred any thromboembolic event, non-gastrointestinal fistula or female genital tract fistula within 6 monthsprior to C1D
- •With cirrhosis of Child-Pugh B or C.
- •Active or unstable viral hepatitis; or active tuberculosis.
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- •received live vaccines prior 30 days within the first dose.
- •take apart in other clinical studies at the same time.
- •known to be allergic to any component of AK109, other monoclonal antibodies or any therapeutic protein.
- •mental illness, drug abuse, or alcohol dependence that may affect compliance with the test requirements.
- •Any treatment risk or condition that interferes with the study by the investigator judged.
研究组 & 干预措施
AK109
Experimental
干预措施: AK109 (Drug)
结局指标
主要结局
Number of subjects experiencing dose-limiting toxicities (DLTs)
时间窗: During the first 4 weeks
DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and 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 first cycle (4 weeks) of treatment.
次要结局
- Objective response rate (ORR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Adverse events (AEs)(From the time of informed consent signed through to 60 days after last dose of AK109)
- Progression-free survival (PFS)(Up to 2 years)
- Number of subjects who develop detectable anti-drug antibodies (ADAs)(From first dose of AK109 through 30 days after last dose of AK109)
- Observed pharmacokinetics (PK) exposure of AK109(From first dose of AK109 through 30 days after last dose of AK109)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway MutationsAdvanced Solid Tumors With MAPK Pathway MutationsNCT05886920D3 Bio (Wuxi) Co., Ltd67
Unknown
1 期
Clinical Study of JS201 in Patients With Advanced Malignant TumorsPatients With Advanced Malignant TumorsNCT04956926Shanghai Junshi Bioscience Co., Ltd.244
终止
1 期
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHLNon-Hodgkins LymphomaChronic Lymphocytic LeukemiaNCT04240704Novartis Pharmaceuticals25
尚未招募
1 期
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 AlterationsSolid Tumors With FGFR2 Alterations, AdultNCT062879183H (Suzhou) Pharmaceuticals Co., Ltd.130
招募中
1 期
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid TumorAdvanced Solid TumorsRefractory LymphomaRelapsed Hematologic MalignancyNCT06615193Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.111