NCT06826040招募中1 期
A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SKB445 for Injection in Patients With Advanced Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Number of subjects achieving Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.
详细描述
This is an open-label, dose-escalation, multicenter study to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor activity of SKB445 monotherapy in patients with advanced solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of signing the ICF: age between 18 -75 years, male or female.
- •subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to
- •Expected survival ≥ 3 months.
- •Subjects with adequate organ and bone marrow function confirmed by laboratory results
- •Subjects of childbearing potential (male or female) must use effective medical contraception during the study
- •Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.
排除标准
- •Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
- •Has had major surgery within 4 weeks prior to the first dose.
- •Has known history of allergy to any component of SKB445 or SKB
- •Has a known previous or concurrent other malignancies within 3 years prior to first dose.
- •Presence of active central nervous system (CNS) metastases.
- •Has uncontrolled or severe cardiovascular disease.
- •Has uncontrolled systemic diseases.
- •Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
- •Subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study.
- •Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- •Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.
研究组 & 干预措施
Dose Escalation Phase
Experimental
Subject will be dosed with SKB445 for injection q3w
干预措施: SKB445 for injection (Drug)
结局指标
主要结局
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: From date of initial dose until up to 21 days for treatment
DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.
次要结局
- Objective Response Rate (ORR)(Up to 3 years)
- Progression Free Survival (PFS)(Up to 3 years)
- Duration of Response (DOR)(Up to 3 years)
- Overall Survival (OS)(Up to 3 years)
研究者
研究点 (1)
Loading locations...
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