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
试验速览
- 阶段
- 1/2 期
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Frequency and severity of DLT (Part 1); Overall response rate per the RECIST version 1.1 in subjects with selected advanced solid tumors (Part 2); JNJ-63723283 PK parameters after 1st dose administration as observed in Part 3 and JNJ-63723283 PK parameters after 4th dose as observed during Q3W dosing in Part 4
研究概览
简要总结
To identify the RP2D(s) for JNJ-63723283 (Part 1), To assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in subjects with selected advanced cancers including NSCLC, melanoma, renal, bladder, SCLC, gastric/esophageal cancer, and MSI-H or dMMR CRC (Part 2), To determine a SC RP2D as defined by a dose regimen for JNJ-63723283 SC delivery which achieves similar exposure as with JNJ-63723283 IV delivery at the RP2Ds for IV administration (Part 3 and Part 4)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •4.Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •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
- •Parts 1 to 4: Have evaluable disease
排除标准
- •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 half lives, 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
结局指标
主要结局
Frequency and severity of DLT (Part 1); Overall response rate per the RECIST version 1.1 in subjects with selected advanced solid tumors (Part 2); JNJ-63723283 PK parameters after 1st dose administration as observed in Part 3 and JNJ-63723283 PK parameters after 4th dose as observed during Q3W dosing in Part 4
Frequency and severity of DLT (Part 1); Overall response rate per the RECIST version 1.1 in subjects with selected advanced solid tumors (Part 2); JNJ-63723283 PK parameters after 1st dose administration as observed in Part 3 and JNJ-63723283 PK parameters after 4th dose as observed during Q3W dosing in Part 4
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen - Cilag International