A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancers

Fujikawa Ei0 个研究点目标入组 413 人开始时间: 2023年1月31日最近更新: 2024年5月27日

研究概览

暂无简介。

•Inclusion Criteria:
•- Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
•- Parts 1-4: Has thyroid function laboratory values within normal range
•- Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test
•- Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
•- For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy
•- Parts 1 to 4: Have evaluable disease

•Exclusion Criteria:
•- Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements
•- Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody
•- Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 halflives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration
•- Grade 3 or higher toxicity effects from previous treatment with immunotherapy
•- A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug

发起方

Fujikawa Ei