A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 3
- 主要终点
- Incidence of dose-limiting toxicity (DLT) (phase IB)
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 and efficacy of SHR-9839 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
- •Aged 18-75 years old (inclusive), regardless of gender.
- •Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
- •At least one measurable tumor lesion according to RECIST v1.
- •ECOG performance score of 0-
- •Life expectancy ≥ 12 weeks.
- •Adequate bone marrow and organ function.
- •Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.
排除标准
- •Patients with active central nervous system ( CNS ) metastases.
- •Spinal cord compression not be cured by surgery or radiotherapy.
- •Subjects with uncontrollable tumor-related pain.
- •Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
- •Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
- •Received > 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
- •Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
- •Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
- •History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
- •Serious cardiovascular and cerebrovascular diseases.
- •Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
- •History of immunodeficiency, including HIV test positive.
- •Active hepatitis B or hepatitis C infection.
- •History of severe allergic reactions to any component of any study drug to be accepted.
- •Known history of alcohol or drug dependence.
- •Mental disorders or poor compliance.
- •Pregnant or lactating women.
- •Patients with any active, known or suspected autoimmune disease.
- •Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study.
- •Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.
研究组 & 干预措施
SHR-9839 combined with Almonertinib
干预措施: SHR-9839 ； Almonertinib (Drug)
SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy
干预措施: SHR-9839 for Injection (sc) (Drug)
SHR-9839 combined with SHR-A2009
干预措施: SHR-9839 for Injection (Drug)
SHR-9839 combined with SHR-A1921
干预措施: SHR-9839 for Injection (Drug)
SHR-9839 (sc) + SHR-1316 + Platinum-based chemotherapy
干预措施: Paclitaxel injection (Drug)
SHR-9839 combined with SHR-A2009
干预措施: SHR-A2009 for Injection (Drug)
SHR-9839 combined with SHR-A1921
干预措施: SHR-A1921 for Injection (Drug)
SHR-9839 combined with Pemetrexed + Carboplatin
干预措施: SHR-9839 for Injection (Drug)
SHR-9839 combined with Pemetrexed + Carboplatin
干预措施: Carboplatin for injection (Drug)
SHR-9839 combined with Almonertinib
干预措施: SHR-9839 for Injection (Drug)
SHR-9839 combined with Almonertinib
干预措施: Almonertinib Mesilate Tablets (Drug)
SHR-9839(sc) + SHR-1316
干预措施: SHR-9839 for Injection (sc) (Drug)
SHR-9839 combined with Pemetrexed + Carboplatin
干预措施: Pemetrexed Disodium for Injection (Drug)
SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc)
干预措施: Paclitaxel injection (Drug)
SHR-1316 + Platinum-based chemotherapy ± SHR-9839(sc)
干预措施: SHR-9839 for Injection (sc) (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicity (DLT) (phase IB)
时间窗: 21 days after the first dose was administered to each subject，Up to approximately 24 months.
Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase IB)
时间窗: Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.
Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0)
Objective Response Rate (ORR) (phase II).
时间窗: The first treatment lasted until disease progression，Up to approximately 24 months.
Evaluated using RECIST 1.1
次要结局
- Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II)(Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 24 months.)