NCT05199753已完成1 期
A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 6
- 主要终点
- Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
研究概览
简要总结
This is a first-in-human, Phase I/II, open-label, multi-centre, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumour activity of LM-108 as a single agent or in combination with an anti-PD-1 mAb in subjects with solid tumours.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
- •At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.
- •Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose
排除标准
- •Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
- •Uncontrolled tumour-related pain
- •Known central nervous system (CNS)
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Use of inhaled corticosteroids
- •Known history of autoimmune disease
- •Use of any live attenuated vaccines within 28 days
- •Have severe cardiovascular disease
- •Uncontrolled or severe illness
- •History of immunodeficiency disease
- •Active malignancies which are likely to require the treatment.
- •Child-bearing potential female
- •Have psychiatric illness or disorders
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LM-108 combination dose expansion
Experimental
干预措施: An Anti-PD-1 Antibody (Drug)
LM-108 Dose Escalation
Experimental
干预措施: LM-108 (Drug)
LM-108 Dose Expansion
Experimental
干预措施: LM-108 (Drug)
LM-108 combination dose escalation
Experimental
干预措施: LM-108 (Drug)
LM-108 combination dose escalation
Experimental
干预措施: An Anti-PD-1 Antibody (Drug)
LM-108 combination dose expansion
Experimental
干预措施: LM-108 (Drug)
结局指标
主要结局
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
时间窗: 126 weeks
Incidence of adverse events (AEs)
时间窗: 126 weeks
Incidence of dose-limiting toxicity (DLT)
时间窗: 126 weeks
Incidence of serious adverse event (SAE)
时间窗: 126 weeks
次要结局
- PK Parameter: Volume of Distribution at Steady-State (Vss)(126 weeks)
- PK Parameter: Degree of Fluctuation (DF)(126 weeks)
- Incidence of anti-drug antibodies to LM-108(126 weeks)
- Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for LM-108(126 weeks)
- PK Parameter: Minimum Observed Concentration (Cmin) for LM-108(126 weeks)
- PK Parameter: Area Under the Concentration-time Curve (AUC) for LM-108(126 weeks)
- PK Parameter: Steady State Maximum Concentration (Cmax,ss)(126 weeks)
- PK Parameter: Accumulation Ratio (Rac)(126 weeks)
- PK Parameter: Steady State Minimum Concentration (Cmin, ss)(126 weeks)
- PK Parameter: Systemic Clearance at Steady State (CLss)(126 weeks)
- PK Parameter: Elimination Half-life (t 1/2)(126 weeks)
- PK Parameter: Time of Maximum Observed Concentration (Tmax) for LM-108(126 weeks)
研究者
研究点 (6)
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