NCT04207463Unknown2 期
A Phase II, Open, Single-arm, Multi-cohort, Multicenter Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
AK105 is a humanized monoclonal antibody that specially binds to PD-1. Anlotinib is a small molecule tyrosine kinase inhibitor. Based on the mechanism study, tumor vascular abnormalities promote tissue hypoxia and increase lactic acid, thereby activating immunosuppression and inhibiting T cell function. Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cohort 1：Histopathologically confirmed metastatic or inoperable cholangiocarcinoma failed with first-line or above chemotherapy.
- •Cohort 2： Histopathologically confirmed recurrent or metastatic colorectal cancer that is not suitable for surgery with MSI-H or dMMR.
- •Cohort 3： Histopathologically confirmed metastatic or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.
- •Cohort 4：Histopathologically confirmed local progression or metastatic urothelial carcinoma that is not suitable for surgery.
- •Cohort 5：Low- and medium-grade (G1 or G2) late gastrointestinal pancreatic neuroendocrine tumor (NET) subjects diagnosed by pathology." 2.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
- •3.At least one measurable lesion. 4.The main organs function are normally.
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- •Understood and signed an informed consent form.
排除标准
- •1.Has used anti-angiogenic drugs such as bevacizumab, erlotinib, apatinib, sorafenib, sunitinib, and endothelium or against PD-1, PD-L1 and other related immunotherapeutic drugs.
- •HER2 positive in cohort
- •Has received chemotherapy, radiotherapy or other treatments within 4 weeks prior to the first dose.
- •4.Has brain metastases with symptoms or symptoms control for less than 2 months.
- •5.Has diagnosed and/or treated additional malignancy within 5 years prior to the first dose.
- •6.Has multiple factors affecting oral medication. 7.Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •8.Has unrelieved spinal cord compression. 9.Imaging shows that tumors invade large blood vessels. 10.Has hemoptysis within 1 month prior to the first dose and maximum daily hemoptysis ≥2.5 mL.
- •11.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade
- •12.Has received surgery, or unhealed wounds within 4 weeks before the first dose.
- •Has artery/venous thrombosis prior to the first dose within 6 months.
- •Has drug abuse history that unable to abstain from or mental disorders
- •Has any serious and / or uncontrolled disease.
- •Has received vaccination or attenuated vaccine within 4 weeks prior to the first dose.
- •17.Hypersensitivity to recombinant humanized anti-PD-1 monoclonal or its components.
- •Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first dose.
- •19.Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10 mg/day of prednisone or other therapeutic hormones) and continued to be used for 2 weeks prior to the first dose
- •Has participated in other anticancer drug clinical trials within 4 weeks.
- •According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
研究组 & 干预措施
Anlotinib and AK105 injection
Experimental
AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
干预措施: AK105 (Drug)
Anlotinib and AK105 injection
Experimental
AK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
干预措施: Anlotinib (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 96 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR).
次要结局
- Progression-free survival (PFS)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Disease control rate（DCR）(up to 96 weeks)
- Overall survival (OS)(up to 120 weeks)
研究者
研究点 (7)
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