NCT06092268尚未招募1 期
A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 270
- 主要终点
- Objective Response Rate (ORR) (phase II).
研究概览
简要总结
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age 18 to 75 years old (inclusive), Female or male
- •Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
- •Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
- •At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
- •ECOG performance score of 0-1;
- •Expected survival time ≥ 12 weeks;
- •Adequate bone marrow and organ function
- •Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
排除标准
- •Subjects with active central nervous system (CNS) metastases.
- •Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
- •Subjects with uncontrolled tumor-related pain
- •Clinically uncontrollable third space fluid
- •Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
- •Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- •Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
- •Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- •Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
- •Serious cardiovascular disease
- •Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases
- •Presence of severe infection within 4 weeks prior to first dose of study drug
- •Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug
- •Arterial/venous thrombotic events within 3 months prior to the first study dose
- •History of immunodeficiency, including a positive HIV test
- •Presence of active hepatitis B or C;
- •History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product.
- •Known history of alcohol or drug dependence or addiction;
- •Persons with mental disorders or poor compliance;
研究组 & 干预措施
Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets
Experimental
干预措施: SHR-A2009 for injection ； Almonertinib Mesilate Tablets (Drug)
Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection
Experimental
干预措施: SHR-A2009 for injection；Adebrelimab Injection (Drug)
结局指标
主要结局
Objective Response Rate (ORR) (phase II).
时间窗: 2 years
Incidence of dose-limiting toxicity (DLT) (phase IB)
时间窗: 21 days after the first dose was administered to each subject.
次要结局
- PK parameter: toxin-binding antibody of SHR-A2009(through study completion, an average of 2 years)
- PK parameter: free toxin of SHR-A2009(through study completion, an average of 2 years)
- Plasma concentration of Adebrelimab(through study completion, an average of 2 years)
- Duration of response(DoR )(One year after the last subject was enrolled in the group)
- Progression Free Survival(PFS)(2 years after the last subject was enrolled in the group)
- Objective response rate(2 years after the last subject was enrolled in the group)
- overall survival (OS) (phase IB)(3 years after the last subject was enrolled in the group)
- Incidence of AEs（Phase II (efficacy expansion phase)）(from Day1 to 90 days after last dose)
- Incidence of SAEs（Phase II (efficacy expansion phase)）(from Day1 to 90 days after last dose)
- PK parameter: total antibody of SHR-A2009(through study completion, an average of 2 years)
- Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)(through study completion, an average of 2 years)
研究者
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