A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB410 for Injection in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 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 SKB410 for injection in patients with advanced solid tumors.
详细描述
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, PK profile, and anti-tumor efficacy of SKB410 for injection in patients with advanced solid tumors.This is a dose escalation study , and subjects with advanced solid tumors will be enrolled to receive SKB410 for Injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •At the time of signing the ICF: age ≥ 18 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 within 3 days prior to the first dose.
- •Subjects of childbearing potential (male or female) must use effective medical contraception during the study and continue contraception until 210 days after the last dose for female subjects and until 120 days after the last dose for male subjects.
- •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 received radiotherapy within 4 weeks prior to the first dose.
- •Has had major surgery within 4 weeks prior to the first dose.
- •Has received strong cytochrome P450 (CYP3A4) inhibitors or inducers (see Annex 4) within 2 weeks prior to the first dose or within 5 half-lives of known drug, whichever is longer.
- •Has not recovered to normal or ≤ Grade 1 from any AE and/or complication due to any prior therapy (except alopecia or pigmentation).
- •Has known history of allergy to any component of SKB410 or other monoclonal antibodies.
- •Has a known previous or concurrent other malignancies within 5 years prior to signing the ICF.
- •Presence of active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Has active autoimmune disease with systemic therapy or immunosuppressive therapy within 2 years prior to signing the ICF.
- •Has uncontrolled or severe cardiovascular disease.
- •Has uncontrolled systemic diseases.
- •Presence of clear neurological or psychiatric disorder.
- •Has active infection requiring systemic.
- •Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
- •Pregnant or lactating.
- •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
Several dose levels are planned in the study and administered every 2 weeks.
干预措施: SKB410 for injection (Drug)
结局指标
主要结局
Number of subjects achieving Dose-limiting toxicity (DLT)
时间窗: From data of initial dose until up to 28 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.
Maximum Tolerated Dose (MTD)
时间窗: From data of initial dose until up to 28 days for treatment
MTD refers to the highest dose at which the subject's DLT incidence meets the EWOC principle (probability of DLT incidence exceeding 33% is less than 25%) during the DLT observation period.
次要结局
未报告次要终点