jRCT2041220131暂停不适用
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
- 不适用
- 状态
- 暂停
- 入组人数
- 413
- 主要终点
- Frequency and Severity of Dose-Limiting Toxicity (DLT)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Frequency and Severity of Dose-Limiting Toxicity (DLT)
时间窗: Up to 2 years 6 months
Frequency and severity of dose-limiting toxicity will be reported.
Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors
时间窗: Up to 2 years 6 months
Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau])
时间窗: Up to 2 years 6 months
AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.
次要结局
- Number of Participants With Adverse Events (AEs) as a Measure of Safety(Up to 2 years 6 months)
- Maximum Observed Serum Concentration (Cmax)(Up to 2 years 6 months)
- Area Under the Serum Concentration Versus Time Curve Between time t1 and t2 (AUC [t1-t2])(Up to 2 years 6 months)
- Elimination Half-Life (t1/2)(Up to 2 years 6 months)
- Total Systemic Clearance of (CL)(Up to 2 years 6 months)
- Volume of Distribution at Steady-State (Vss)(Up to 2 years 6 months)
- Accumulation Ratio (R)(Up to 2 years 6 months)
- Average Concentration (Cavg) of JNJ-63723283(Up to 2 years 6 months)
- Area Under the Serum Concentration Versus Time Curve Between Time Zero and Time t (AUC [0-t])(Up to 2 years 6 months)
- Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity])(Up to 2 years 6 months)
- Concentration Observed at the Last Timepoint Prior to Dosing (Ctrough)(Up to 2 years 6 months)
- Presence of Anti-JNJ-63723283 Antibodies and Effect on Serum JNJ-63723283 Concentrations(Up to 2 years 6 months)
- Overall Response Rate (ORR) per Immune-Related Response Criteria (irRC)(Up to 2 years 6 months)
- Duration of Response (DOR) per RECIST v1.1(Up to 2 years 6 months)
- Duration of Response (DOR) per irRC(Up to 2 years 6 months)
- Clinical Benefit Rate (CBR) per RECIST v1.1(Up to 2 years 6 months)
- Clinical Benefit Rate per irRC(Up to 2 years 6 months)
- Progression-free Survival (PFS) per RECIST v1.1(Up to 2 years 6 months)
- Progression-free Survival (PFS) per irRC(Up to 2 years 6 months)
- Overall Survival (OS)(Up to 2 years 6 months)
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