A Phase Ib Study of the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-10504 Combined Therapy in Advanced Non-small Cell Lung Cancer Patients
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- 入组人数
- 400
- 主要终点
- TEAE
概览
简要总结
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
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
- •Cohort1:participants with EGFR mutation advanced stage NSCLC，disease progression on or after prior treatment；
- •Cohort2:participants with MET position advanced stage NSCLC，disease progression on or after prior treatment；
- •With at least 1 target lesion according to RECIST 1.
- •Appropriate organ function
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.
- •Minimum expected survival longer than 12 weeks
- •Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.
- •Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.
排除标准
- •Insufficient wash out duration of prior systemic anticancer therapy
- •Local radiotherapy within 2 weeks prior to first dose of investigational drug
- •Pleural/abdominal effusion requires clinical intervention
- •Major surgery within 4 weeks prior to first dose of investigational drug
- •History of drugs may prolong QT interval
- •Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).
- •Presence of brain metastasis or carcinomatous meningtitis
- •History of other primary malignancies
- •Significant, uncontrolled, or active cardiovascular diseases
- •Severe or poorly controlled diabetes
研究组 & 干预措施
Cohort 1c
干预措施: HS-10504 (Drug)
Cohort 1c
干预措施: HS-20122 (Drug)
Cohort 1a
干预措施: HS-10504 (Drug)
Cohort 1a
干预措施: SHR-A2102 (Drug)
Cohort 1b
干预措施: HS-10504 (Drug)
Cohort 1b
干预措施: SHR-A2009 (Drug)
Cohort 1d
干预措施: HS-10504 (Drug)
Cohort 1d
干预措施: HS-20117 (Drug)
Cohort 2
干预措施: HS-10504 (Drug)
Cohort 2
干预措施: SHR-1826 (Drug)
结局指标
主要结局
TEAE
时间窗: Through the full duration of this trial, approximately 2 years
incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0
TRAE
时间窗: Through the full duration of this trial, approximately 2 years
incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0
SAE
时间窗: Through the full duration of this trial, approximately 2 years
incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0
RP2D for Combination
时间窗: Through the full duration of this trial, approximately 2 years
To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-10504 based therapy in subjects with EGFR mutation-positive locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial
ORR
时间窗: Through the full duration of this trial, approximately 2 years
Investigator evaluated overall response rate, to evaluate the efficacy of each combination
次要结局
未报告次要终点