NCT06703177招募中1 期
Phase IB/II Study of Safety, Tolerability and Efficacy of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 876
- 试验地点
- 1
- 主要终点
- RP2D (Phase 1)
研究概览
简要总结
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with advanced solid tumors.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation and written informed consent;
- •18-75 years older, no gender limitation;
- •Eastern Cooperative Oncology Group (ECOG) score: 0-1;
- •With a life expectancy ≥ 3 months;
- •Pathologically diagnosed advanced solid tumor;
- •Be able to provide fresh or archived tumour tissue;
- •At least one measurable lesion according to RECIST v1.1;
- •Adequate bone marrow reserve and organ function;
- •Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
排除标准
- •Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- •Previous or co-existing malignancies;
- •Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded;
- •Uncontrollable tumor-related pain;
- •Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody;
- •Received systemic antitumor therapy before the first dose;
- •Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing;
- •For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment;
- •Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment;
- •Unresolved CTCAE 5.0>grade 2 toxicities from previous anticancer therapy;
- •A history of interstitial pneumonia/non-infectious pneumonia;
- •Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms;
- •Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing;
- •With poorly controlled or severe cardiovascular disease;
- •Active hepatitis B, hepatitis C;
- •Patients with a history of immunodeficiency;
- •Severe infection 30 days before the first dose.
研究组 & 干预措施
Single group
Experimental
干预措施: Fluorouracil Injection (Drug)
Single group
Experimental
干预措施: Calcium Folinate Injection (Drug)
Single group
Experimental
干预措施: Adebrelimab Injection (Drug)
Single group
Experimental
干预措施: SHR-1826 (Drug)
Single group
Experimental
干预措施: SHR-4642 (Drug)
Single group
Experimental
干预措施: SHR-9839 (Drug)
Single group
Experimental
干预措施: SHR-8068 (Drug)
Single group
Experimental
干预措施: Bevacizumab Injection (Drug)
Single group
Experimental
干预措施: Capecitabine tablets (Drug)
结局指标
主要结局
RP2D (Phase 1)
时间窗: Screening up to study completion, an average of 1 year.
AE (Phase 1)
时间窗: Screening up to study completion, an average of 1 year.
Objective response rate (ORR) (Phase 2)
时间窗: Screening up to study completion, an average of 1 year.
次要结局
- Objective response rate (ORR) (Phase 1)(Screening up to study completion, an average of 1 year.)
- Disease control rate (DCR) (Phase 1)(Screening up to study completion, an average of 1 year.)
- Duration of response (DoR) (Phase 1)(Screening up to study completion, an average of 1 year.)
- Progression-free survival (PFS) (Phase 1)(Screening up to study completion, an average of 1 year.)
- Overall survival (OS) (Phase 1)(Screening up to study completion, an average of 1 year.)
- Drug Resistant Antibody (ADA) (Phase 1)(Screening up to study completion, an average of 1 year.)
- Blood concentration of SHR-1826 (Phase 1)(Screening up to study completion, an average of 1 year.)
- Blood concentration of free toxin SHR169265 (Phase 1)(Screening up to study completion, an average of 1 year.)
- Disease control rate (DCR) (Phase 2)(Screening up to study completion, an average of 1 year.)
- Duration of response (DoR) (Phase 2)(Screening up to study completion, an average of 1 year.)
- Progression-free survival (PFS) (Phase 2)(Screening up to study completion, an average of 1 year.)
- Overall survival (OS) (Phase 2)(Screening up to study completion, an average of 1 year.)
- AE (Phase 2)(Screening up to study completion, an average of 1 year.)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Study of SHR-1826 for Injection in Combination With Other Antitumor Therapies in Subjects With NSCLCNon-small Cell Lung Cancer (NSCLC)NCT06754930Suzhou Suncadia Biopharmaceuticals Co., Ltd.400
已完成
1 期
A Phase Ib/II Study Of JS015 Combination Therapy in Advanced Solid TumorsAdvanced Solid TumorNCT06139211Shanghai Junshi Bioscience Co., Ltd.66
尚未招募
1 期
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid TumorsLocally Advanced or Metastatic Solid Tumors Harboring KRAS G12C MutationNCT06435455Suzhou Genhouse Bio Co., Ltd.126
招募中
1 期
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E MutationNon Small Cell Lung CancerNCT05641493Shanghai Henlius Biotech49
招募中
1 期
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT06474455Shanghai Hengrui Pharmaceutical Co., Ltd.156