A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of LNP8701 in Subjects with Metastatic Solid Tumors - NI

upin Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•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) v1.1.
•Subjects must have an ECOG performance status of 0 or 1.
•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.

•1. Subjects with symptomatic central nervous system (CNS)
•metastases.
•2. History of another primary malignancy except for treated
•non-melanoma skin or cervical cancer in situ or ductal cancer in situ.
•3. Evidence of clinically significant organ dysfunction.
•4. Any major surgery, as determined by the investigator within 30
•days of screening.
•5. Positive screen test for HIV, Hepatitis B, Hepatitis C.
•6. History of any relevant allergy/hypersensitivity to the study drugs
•or its excipient
•7. 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.
•8. 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.

发起方

upin Limited