A Phase 1b/2 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.5 个研究点分布在 1 个国家目标入组 309 人开始时间: 2022年5月17日最近更新: 2023年4月27日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
入组人数: 309
试验地点: 5
主要终点: Dose-limiting toxicity in dose escalation part

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.

详细描述

This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part.

In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks.

In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
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

•Age ≥18 years old, male or female
•Life expectancy≥12 weeks;
•Phase 1b: Patients with advanced solid tumors diagnosed by histology or cytology, who have been failure to previous standard treatments; Phase 2: Patients with HNSCC, NPC, OC, NSCLC, SCLC, HCC, cHL and other solid tumors diagnosed by histology or cytology, who have been failure to first-line standard treatment (including PD-1/L1) at least;
•ECOG PS of 0 or 1;
•Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation.
•Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0);

排除标准

•Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein;
•Patients with symptomatic or progressive central nervous system (CNS) metastasis;
•Uncontrolled hypertension, pulmonary hypertension or unstable angina, myocardial infarction within 6 months prior to administration; a history of chronic heart failure (NYHA G3/4); severe arrhythmia;
•A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
•A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency;
•With other malignant tumors;
•Diseases that may cause gastrointestinal bleeding or perforation;
•Uncontrollable pleural, peritoneal or pericardial effusions;
•A history of immunodeficiency;
•A history of autoimmune diseases;
•Uncontrolled severe active infections.

研究组 & 干预措施

Dose Escalation Part

Experimental

Mutiple dose level cohorts in the dose escalation part

干预措施: IMM01 (Drug)

Dose Escalation Part

Experimental

Mutiple dose level cohorts in the dose escalation part

干预措施: Tislelizumab (Drug)