A Phase I/II, Open-Label, Dose Escalation and Expansion Study of LM-108 as a Single Agent or in Combination With Pembrolizumab in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- DLT
研究概览
简要总结
A Phase I/II, 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 Pembrolizumab in Advanced Solid Tumors
详细描述
A Phase I/II, 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 Pembrolizumab in Advanced Solid Tumors
The study schedule includes screening visit (28 days prior to accept the investigational medicinal product (IMP)), treatment visit (accept IMP for the first time to the end of treatment (EOT)/early withdrawal), and follow-up visit (28 days after the EOT/early withdrawal).
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 Dose Escalation
Drug: LM-108 Administered intravenously
干预措施: LM-108 (Drug)
LM-108 Dose Expansion
Drug: LM-108 Administered intravenously
干预措施: LM-108 (Drug)
LM-108 Combination Dose Escalation
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
干预措施: LM-108 (Drug)
LM-108 Combination Dose Escalation
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
干预措施: An Anti-PD-1 Antibody (Drug)
LM-108 Combination Dose Expansion
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
干预措施: LM-108 (Drug)
LM-108 Combination Dose Expansion
Drug: LM-108 Administered intravenously Drug: An Anti-PD-1 Antibody Administered intravenously
干预措施: An Anti-PD-1 Antibody (Drug)
结局指标
主要结局
DLT
时间窗: 21 days
Incidence of dose-limiting toxicity (DLT)
SAE
时间窗: 126 weeks
Incidence of serious adverse event
AEs
时间窗: 126 weeks
Incidence of adverse events
Incidence of clinical significant in laboratory examinations
时间窗: 126 weeks
Incidence of clinical significant in laboratory examinations, including hematology, urinalysis, blood biochemistry, coagulation tests and thyroid function.
次要结局
- Cmax(126 weeks)
- Vss(126 weeks)
- Tmax(126 weeks)
- AUC(126 weeks)
- Rac(126 weeks)
- Incidence of anti-drug antibodies to LM-108(126 weeks)
- Cmin(126 weeks)
- Cmax,ss(126 weeks)
- Cmin, ss(126 weeks)
- CLss(126 weeks)
- t 1/2(126 weeks)
- DF(126 weeks)