jRCT2080223997已完成1 期
A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants with 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
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Radiographically, histologically, or cytologically confirmed advanced or refractory solid tumor(s) that is metastatic or unresectable, and previously received or was ineligible for standard treatment option. Participants with solid tumor(s) for which anti-PD-1 or anti-PD-L1 antibody as a monotherapy is approved in Japan are eligible.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Thyroid function laboratory values within normal range
- •A woman must be:
- •a) Not of childbearing potential;
- •b) Of childbearing potential and practicing a highly effective, preferably user-independent method of contraception (failure rate of less than (<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer. Especially participants receiving erdafitinib must agree to use two contraceptive methods and one must be user-independent method;
- •c) Agree not to donate eggs (ova, oocytes), during the study and continue for 5 months following discontinuation of JNJ-63723283 or 3 months following discontinuation of erdafitinib, whichever is longer
- •A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person and must agree not to donate sperm for 5 months following discontinuation of JNJ-63723283 or 5 months following discontinuation of erdafitinib, whichever is longer
排除标准
- •Had prior treatment with an anti-PD-1 antibody, anti-PD-L1 antibody or anti-PDL2 antibody within 30 days of first study drug administration and/or has an ongoing Grade 2 or higher immunotherapy-related toxicity. If the subject has an experience of treatment with these agents, the subject must not have had severe immunotherapy-related toxicity
- •History of or concurrent interstitial lung disease
- •Active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents
- •Grade 3 or higher toxicity effects from previous treatment with immunotherapy
- •Has taken immunosuppressive doses of systemic medications, such as corticosteroids doses greater than (>) 10 milligram per day (mg/day) prednisolone or equivalent), within 2 weeks before the planned first dose of study drug
结局指标
主要结局
Number of Participants with Dose Limiting Toxicity (DLT)
时间窗: Up to 6 weeks (maximum)
Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
时间窗: Up to 6 weeks (maximum)
Phase 1a and Phase 1b: Severity of DLT as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
次要结局
- Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity(Approximately up to 3 years)
- Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Maximum Serum Concentration (Cmax) of JNJ-63723283(Approximately up to 3 years)
- Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283(Approximately up to 3 years)
- Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283(Approximately up to 3 years)
- Area Under the Serum Concentration-Time Curve Between 2 Defined Sampling Points, (t1 and t2) (AUC[t1-t2]) of JNJ-63723283(Approximately up to 3 years)
- Elimination Half-Life (t1/2) of JNJ-63723283(Approximately up to 3 years)
- Total Systemic Clearance (CL) of JNJ-63723283(Approximately up to 3 years)
- Volume of Distribution at Steady-State (Vss) of JNJ-63723283(Approximately up to 3 years)
- Cmax of Erdafitinib(Approximately up to 3 years)
- Ctrough of Erdafitinib(Approximately up to 3 years)
- Numb+H62+H63(Approximately up to 3 years)
研究者
研究点 (1)
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