NCT05167448进行中（未招募）1 期
Phase I/II Clinical Trial of ES104 in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer Who Have Failed Systemic Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Phase 1: The frequency and severity of adverse events of ES104
研究概览
简要总结
The purpose of this open-label, Multicenter Phase I/II study is to evaluate the safety, tolerability, preliminary anti-tumor efficay, pharmacokinetics, anti-drug antibodies and biomarkers of ES104 in patients with unresectable locally advanced or metastatic colorectal cancer who have failed systemic therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Ability to understand and the willingness to sign a written informed consent form.
- •Locally advanced or metastatic colorectal adenocarcinoma confirmed by pathology and not surgically resectable, having received systemic therapy and failed.
- •At least one measurable lesion is required (RECIST v1.1)
- •Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or
- •Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks.
- •Adequate organ function, as assessed by the results of the laboratory tests specified in the protocol.
- •Male and female subjects of childbearing potential must be willing to use effective contraceptive methods, from the time of signing informed consent and for the duration of study participation through 180 days following the last dose of study drug.
排除标准
- •Receipt of any systemic antitumor therapy within 28 days prior to the first dose of study drug.
- •Known history of severe allergy to any monoclonal antibody or study drug excipient.
- •The subject has received or is receiving treatment in another clinical trial within 28 days prior to the first dose of study drug (except for participation in the overall survival follow-up of a study)
- •Receipt of antiplatelet agents or anticoagulants for therapeutic purposes within 14 days prior to the first dose of study drug.
- •Receipt of live vaccination within 28 days prior to the first dose of study drug.
- •Prior history of allogeneic organ transplantation or allogeneic peripheral blood stem cell (PBSC)/bone marrow transplantation treatment.
- •Subject has not recovered from all AEs of previous anticancer therapies to baseline or ≤ Grade 1 per CTCAE v5.0 before the first dose of study drug. Certain exceptions as defined in protocol apply.
- •Subjects with active metastatic brain or meningeal metastases.
- •Patients with other primary malignancies within 5 years before the first dose of study drug. Some exceptions as defined per protocol apply.
- •Major surgery or major traumatic injury within 28 days prior to the first dose of study drug (in the judgment of the Investigator).
- •History of cardiovascular disease as defined by the protocol within the past 5 years.
- •History of bleeding-related illness as defined by the protocol.
- •Presence of severe, unhealed or open wounds and active ulcers or untreated fractures.
- •Known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome.
- •Chronic active hepatitis B or active hepatitis C.
- •Active infection requiring systemic therapy 14 days prior to first dose of study drug.
- •Pregnant or nursing females.
- •Known history of alcohol or drug abuse.
- •Subjects with comorbidities or other conditions that may affect compliance with the protocol or are not suitable for participation in this study in the judgment of the Investigator.
研究组 & 干预措施
Cohort 1 Phase 1
Experimental
干预措施: ES104 (Drug)
Cohort 2 Phase 1
Experimental
干预措施: ES104 (Drug)
RP2D Phase 2
Experimental
干预措施: ES104 (Drug)
结局指标
主要结局
Phase 1: The frequency and severity of adverse events of ES104
时间窗: 1-3 years
The safety profile of ES104 will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Phase 2: The anti-tumor activity of ES104
时间窗: 2-5 years
The Objective Remission Rate (ORR) will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
次要结局
- Phase 1: Maximum observed serum concentration (Cmax) of ES104(1-3 years)
- Phase 2: The frequency and severity of adverse events of ES104(2-5 years)
- Phase 1:Time to Cmax (Tmax) of ES104(1-3 years)
- Phase 1:Area under the serum concentration time curve (AUC) of ES104(1-3 years)
- Phase 1:The clearance of ES104(1-3 years)
- Phase 1: The immunogenicity of ES104(1-3 years)
- Phase 1: The preliminary anti-tumor activity of ES104(1-3 years)
- Phase 2: The anti-tumor activity of ES104(2-5 years)
- Phase 2: The popPK profile of ES104(2-5 years)
- Phase 2: The immunogenicity of ES104(2-5 years)
研究者
研究点 (1)
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