NCT07009457进行中（未招募）1 期
An Open Label, Multicenter Phase I Clinical Study on the Pharmacokinetics, Safety, Tolerability, and Efficacy of SHR-1316 (SC) Combined With Carboplatin and Etoposide in First-line Treatment of Extensive Stage Small Cell Lung Cancer
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
- 24
- 试验地点
- 1
- 主要终点
- SHR-1316 serum trough concentration (Ctrough)
研究概览
简要总结
This study is a multicenter, open label phase I clinical trial aimed at evaluating the pharmacokinetics, tolerability, safety and immunogenicity of SHR-1316 (sc) subcutaneous administration combined with carboplatin and etoposide as first-line treatment for extensive stage small cell lung cancer, and to observe the initial anti-tumor efficacy.
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
- •Patients with extensive stage small cell lung cancer confirmed by histology or cytology; Has not received first-line systemic therapy or immune checkpoint inhibitor treatment for ES-SCLC in the past.
- •ECOG physical fitness score 0-1 points.
- •According to RECIST v1.1, there must be at least one measurable tumor lesion.
- •Expected survival time ≥ 12 weeks.
- •Having sufficient bone marrow and organ function.
- •Participants must give informed consent to this study prior to the trial and voluntarily sign a written informed consent form.
排除标准
- •Patients with central nervous system or meningeal metastases.
- •Spinal cord compression that cannot be cured by surgery and/or radiotherapy cannot be included in the study.
- •Patients diagnosed by researchers with uncontrollable tumor related pain.
- •Symptomatic third space effusion requires repeated drainage, such as pericardial effusion, pleural effusion, and abdominal effusion that cannot be controlled by pumping or other treatments.
- •Having undergone major organ surgery (excluding biopsy) or significant trauma within 4 weeks prior to the first use of the investigational drug, or requiring elective surgery during the trial period.
- •History of idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically significant active pneumonia at screening; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area may participate in this study).
- •Severe infections, including but not limited to bacteremia requiring hospitalization and severe pneumonia, were present within 4 weeks prior to the first medication; Within 2 weeks prior to the first medication, there is an active infection with CTCAE ≥ 2 that requires treatment with systemic antibiotics.
- •Individuals with active pulmonary tuberculosis infection detected through medical history or CT examination within the year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment.
- •History of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplant recipients.
- •Known to have alcohol or drug dependence; Individuals with mental disorders or poor compliance; Pregnant or lactating women; Or the researcher believes that there is a history of other serious systemic diseases or other reasons that make it unsuitable to participate in this clinical study.
研究组 & 干预措施
SHR-1316 (sc) Dose C Group
Experimental
干预措施: SHR-1316 Injection (Drug)
SHR-1316 (sc) Dose C Group
Experimental
干预措施: Etoposide Injection (Drug)
SHR-1316 (sc) Dose A Group
Experimental
干预措施: SHR-1316 (sc) Injection (Drug)
SHR-1316 (sc) Dose A Group
Experimental
干预措施: SHR-1316 Injection (Drug)
SHR-1316 (sc) Dose B Group
Experimental
干预措施: SHR-1316 Injection (Drug)
SHR-1316 (sc) Dose C Group
Experimental
干预措施: Carboplatin Injection (Drug)
SHR-1316 (sc) Dose C Group
Experimental
干预措施: SHR-1316 (sc) Injection (Drug)
SHR-1316 (sc) Dose B Group
Experimental
干预措施: Etoposide Injection (Drug)
SHR-1316 (sc) Dose A Group
Experimental
干预措施: Carboplatin Injection (Drug)
SHR-1316 (sc) Dose A Group
Experimental
干预措施: Etoposide Injection (Drug)
SHR-1316 (sc) Dose B Group
Experimental
干预措施: Carboplatin Injection (Drug)
SHR-1316 (sc) Dose B Group
Experimental
干预措施: SHR-1316 (sc) Injection (Drug)
结局指标
主要结局
SHR-1316 serum trough concentration (Ctrough)
时间窗: Day1 pre-dose to Day28.
Area under the concentration curve from time 0 to 21 days for SHR-1316 (sc) (AUC0-21d)
时间窗: Day1 pre-dose to Day21.
Area under the concentration curve from time 0 to 28 days for SHR-1316 (sc) (AUC0-28d)
时间窗: Day1 pre-dose to Day28.
次要结局
- Maximum Concentration of SHR-1316 (sc) (Cmax)(Day1 pre-dose to Day28.)
- Time to maximum plasma concentration (Tmax)(Day1 pre-dose to Day28.)
- Terminal half-life (t1/2)(Day1 pre-dose to Day28.)
- Incidence and severity of adverse events (AEs)(About 2 years.)
- Objective Response Rate (ORR)(About 2 years.)
- Duration of Relief (DoR)(About 1.5 years.)
- Disease Control Rate (DCR)(About 2 years.)
- Progression-free Survival (PFS)(About 2 years.)
- Overall Survival (OS)(About 3 years.)
研究者
研究点 (1)
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