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 - 63723283LUC1001

Janssen - Cilag International0 个研究点目标入组 6 人开始时间: 2024年6月7日最近更新: 2024年8月21日

研究概览

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•1. Parts 1-4: Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1, 2. Parts 1-4: Has thyroid function laboratory values within normal range, 3. Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test, 4.Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol, 5. Participant must have evaluable disease. 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, 6. Parts 1 to 4: Have evaluable disease

•1. 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, 2. 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, 3. Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration, 4. Grade 3 or higher toxicity effects from previous treatment with immunotherapy, 5. 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

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