A Phase I Clinical Study Evaluating Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Pogression-free survival (PFS) determined by investigators according to RECIST 1.1
研究概览
简要总结
This is a Phase I clinical study of HS-20093. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
详细描述
This is a multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with ES-SCLC. Patients with ES-SCLC without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy) will receive maintenance therapy of HS-20093 in combination with Adebrelimab. Patients will continue treatment until disease progression or other criteria for termination of treatment are met.
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
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Men or women aged more than or equal to (≥) 18 years.
- •Pathologically diagnosed as ES-SCLC.
- •Without disease progression after receiving first-line standard induction therapy (Platinum + Etoposide +PD- (L) 1 inhibitor combination therapy).
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0~
- •Estimated life expectancy >12 weeks.
- •Adequate bone marrow reserve or serious organ dysfunction
- •Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.
- •Females must have evidence of non-childbearing potential.
- •Signed and dated Informed Consent Form.
排除标准
- •Uncontrolled pleural effusion or ascites or pericardial effusion.
- •Known and untreated, or active central nervous system metastases.
- •Active autoimmune diseases or active infectious disease
- •Known to have interstitial pneumonia or immune pneumonia
- •History of severe allergic reaction, serious transfusion reactions or Allergy to any component of HS-20093
- •The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.
- •The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.
- •Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.
- •History of neuropathy or mental disorders, including epilepsy and dementia.
研究组 & 干预措施
HS-20093 and Adebrelimab
干预措施: HS-20093 in combination with Adebrelimab (Drug)
结局指标
主要结局
Pogression-free survival (PFS) determined by investigators according to RECIST 1.1
时间窗: up to approximately 24 months
PFS is defined as the time from date of first dose until the documentation of objective PD or death from any cause in the absence of progression (whichever occurred first), regardless of whether they subsequently received non-study anti-cancer therapy.
次要结局
- Incidence of adverse events (AEs)(From the first dose through 90 days post end of treatment)
- Objective response rate (ORR) assessed by investigator(up to approximately 24 months)
- Disease Control Rate (DCR)(up to approximately 24 months.)
- Duration of response (DOR)(up to approximately 24 months.)
- Overall survival (OS)(up to approximately 24 months.)
- Observed maximum plasma concentration (Cmax) of HS-20093(up to approximately 24 months.)
- Area Under the Plasma Concentration-Time Curve (AUC) of HS-20093(up to approximately 24 months.)
- Percentage of participants with antibodies to HS-20093 in serum(up to approximately 24 months.)