NCT07564466招募中2 期
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 in Participants With Gastrointestinal Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 41
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 in participants with gastrointestinal tumors.
详细描述
This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571 in participants with gastrointestinal tumors. Approximately 120 subjects will be enrolled in this study, including 4 cohorts with approximately 20-30 participants enrolled in each cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
- •Participants must have histologically or cytologically confirmed gastrointestinal tumors.
- •At least one measurable lesion as assessed by the investigator according to RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks as assessed by the investigator.
- •Adequate organ and bone marrow function.
- •Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
- •Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.
排除标准
- •Participants with other malignant tumors within 3 years before the first dose of study treatment.
- •History or current metastases to central nervous system.
- •Current uncontrolled concomitant diseases
- •Clinically severe lung damage due to complications of lung disorder
- •Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
- •A history of severe skin diseases
- •Unresolved toxicity from prior anti-tumor therapy
- •Serious infection within 4 weeks before the first dose of study treatment
- •Known active pulmonary tuberculosis.
- •Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
- •Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
- •Pregnant or breastfeeding women.
- •Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
研究组 & 干预措施
Hepatocellular Carcinoma (HCC) or Bile Duct Cancer (BTC) or other types of gastrointestinal tumors
Experimental
干预措施: SKB571 for injection (Drug)
Gastric Cancer/Gastroesophageal Junction Adenocarcinoma (GC/GEJ)
Experimental
干预措施: SKB571 for injection (Drug)
Oesophageal Squamous Cell Carcinoma (ESCC)
Experimental
干预措施: SKB571 for injection (Drug)
Colorectal Adenocarcinoma (CRC)
Experimental
干预措施: SKB571 for injection (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 24 months
次要结局
- Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)(Up to approximately 24 months)
- Safety and tolerability(Up to approximately 24 months)
- Maximum Plasma Concentration (Cmax) of SKB571-ADC(Up to approximately 24 months)
- Immunogenicity(Up to approximately 24 months)
- Minimum Plasma Concentration(Cmin) of SKB571-ADC(Up to approximately 24 months)
- Maximum Plasma Concentration(Cmax) of SKB571-TAb(Up to approximately 24 months)
- Minimum Plasma Concentration(Cmin) of SKB571-TAb(Up to approximately 24 months)
- Maximum Plasma Concentration (Cmax) of unconjugated KL610348(Up to approximately 24 months)
- Minimum Plasma Concentration(Cmin) of unconjugated KL610348(Up to approximately 24 months)
研究者
研究点 (41)
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