A Phase 1, Open-Label, Multicenter Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IO-108 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody in Adult Patients With Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 14
- 主要终点
- Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab
研究概览
简要总结
This is a Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of IO-108 monotherapy and in combination with anti-PD-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. The study will be conducted in 3 parts, including Part A IO-108 monotherapy dose confirmation; Part B IO-108 + anti-PD-1 dose confirmation, and Part C dose expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥18, and <
- •Part A and Part B Cohort 1: Patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists.
- •Part B Cohort 2 and Part C: Patient with advanced or metastatic solid tumor who meet the specific criteria.
- •Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to
- •Patients must have adequate hematologic function, hepatic function and renal function.
排除标准
- •Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
- •Patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy < 4 weeks prior to their first day of study drug administration.
- •Requires systemic corticosteroids at a dose of >10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose.
- •History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
- •Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab
时间窗: through study completion, an average of 2 years
ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108
时间窗: through study completion, an average of 2 years
AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 in combination with pembrolizumab or tislelizumab
时间窗: through study completion, an average of 2 years
AE severity graded by NCI CTCAE, Version 5.0
次要结局
- Steady state concentration of IO-108(through study completion, an average of 2 years)
- Anti-drug antibodies (ADA) of IO-108(through study completion, an average of 2 years)
- Maximum plasma concentration (Cmax) of IO-108(through study completion, an average of 2 years)
- Preliminary anti-tumor activity(through study completion, an average of 2 years)