NCT04337463Unknown1 期
An Open, Dose-escalation and Expansion Study With a Dual TORC1/2 Inhibitor of ATG-008 Combined With PD-1 Antibody of Toripalimab in Advanced Solid Tumors
Sichuan University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
This is an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Know and voluntarily sign informed consent.
- •Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg.
- •At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.
- •ECOG performance status score is 0 or
- •Blood chemistry test results, meet the following results:
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × normal upper limit (ULN)
- •Total bilirubin ≤ 1.5 × ULN
- •Serum albumin> 29 g / L
- •Creatinine ≤ 1.5 × ULN or 24-hour serum creatinine clearance ≥ 50 mL / min
- •Lipase and amylase ≤ 2 × ULN.
- •Adequate bone marrow function and meets the following results:
- •Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L
- •Platelets ≥ 75 × 10^9 / L
- •Hemoglobin ≥ 90 g / L.
- •Except for hearing loss and hair loss, all toxicity caused by previous anti-tumor therapy must have returned to ≤ Grade 1 (according to NCI-CTCAE version 5.0).
- •Life expectancy is longer than 3 months.
排除标准
- •Have a history of hepatic encephalopathy.
- •Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).
- •Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.
- •Have a history of HIV infection and/or acquired immunodeficiency syndrome
- •Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.
- •Have a history of organ transplantation (eg., liver transplantation).
- •Poorly-controlled pleural or pericardial effusion during the screening period.
- •Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies
- •Suffering from active or previously recurring autoimmune diseases or under such a risk.
- •Systemically immunosuppressive drugs are currently used within 14 days of the first dose.
- •The investigator considers that the complications or other situations of the subject may affect compliance with the protocol, or are not suitable for participation in this study.
- •Subjects with diabetes or glycated hemoglobin (HbA1c)> 7%.
研究组 & 干预措施
ATG-008 and Toripalimab
Experimental
Toripalimab will be combined with ATG-008.
干预措施: ATG-008 (Drug)
ATG-008 and Toripalimab
Experimental
Toripalimab will be combined with ATG-008.
干预措施: Toripalimab (Drug)
结局指标
主要结局
ORR
时间窗: Through study completion (approximately 2 years)
Overall Response Rate
RP2D
时间窗: Within 21 days after dosing
Recommended phase 2 dose
MTD
时间窗: Within 21 days after dosing
Maximum Tolerated Dose
次要结局
- DCR(12 months)
- PFS(12 months)
- OS(12 months)
- AUC(Day 1 - Day 15)
- DOR(12 months)
- Cmax(Day 1 - Day 15)
研究者
Li Zheng
Professor
Sichuan University
研究点 (2)
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