A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of LNP8701 in Subjects with Metastatic Solid Tumors
概览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- To determine Maximum Tolerated Dose (MTD) of LNP8701
概览
简要总结
This is a Phase 1, open label, multi-center study of LNP8701 in subjects with metastatic solid tumors. This study will be a first-in-human study to determine the MTD, to evaluate safety, tolerability, PK and to explore the preliminary efficacy profile of orally administered LNP8701. Also to determine overall response rate (radiological assessment) as per RECIST 1.1 criteria as a monotherapy. To evaluate number of subjects with adverse events and serious adverse events. Number of subjects withdrawn due to related AEs. To check the effect of food on the PK parameters; Cmax, AUC, terminal phase half life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects ≥18 years of age.
- •2.Subjects must have a histologically or cytologically confirmed diagnosis of metastatic solid tumors.
- •3.Subjects with solid tumors must have at least one measurable tumor lesion according to response evaluation criteria in solid tumors (RECIST) v1.
- •Subjects must have an ECOG performance status of 0 or
- •4.Subjects must have clinical laboratory values that meet the following criteria: -Absolute neutrophil count ≥1.5 x 109/L -Platelets ≥100 x 109/L -Hemoglobin ≥9 g/dL -Serum bilirubin ≤1.5 x upper limit of normal (ULN) -Aspartate aminotransferase and alanine aminotransferase ≤3 x ULN in absence of liver metastases; or ≤5 x ULN if the subject has documented liver metastases 5.Subjects with history of disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumor type and disease stage, in the opinion of the investigator.
- •6.Subjects must have a life expectancy ≥12 weeks in the opinion of the Investigator.
排除标准
- •Subjects with symptomatic central nervous system (CNS) metastases.
- •History of another primary malignancy except for treated non-melanoma skin or cervical cancer in situ or ductal cancer in situ.
- •Evidence of clinically significant organ dysfunction.
- •Any major surgery, as determined by the investigator within 30 days of screening.
- •History of any relevant allergy/hypersensitivity to the study drugs or its excipient
- •Use of concomitant medication that might reasonably influence the results of the study prior to study drug administration and at any time during the study.
- •Received any therapy such as chemotherapy, radiotherapy, biologic therapy, immunotherapy, other investigational agent within 30 days or a washout of at least 5 half-lives whichever is long with respect to study drug administration.
结局指标
主要结局
To determine Maximum Tolerated Dose (MTD) of LNP8701
时间窗: From baseline till the end of cycle 1 at each dose level MTD will assessed.
次要结局
- Number of subjects with adverse events (AEs) & serious AEs (SAEs) & PK parameters(At the end of the treatment (approximately 24 weeks).)
研究者
Dr Chirag Shah
Lupin Ltd.