NCT03547037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
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
研究概览
简要总结
The primary purpose of this study is to identify the recommended Phase 2 dose (RP2D) of JNJ-63723283 as a monotherapy (Phase 1a part) and to identify the RP2D of JNJ-63723283 when administered in combination with Erdafitinib (Phase 1b part).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 options. 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; Examples of highly effective contraceptives include: user-independent methods: intrauterine device (IUD) or intrauterine contraceptive system (IUS) and user-dependent methods: combined (estrogen- and progestogen-containing) hormonal contraception or progesterone-containing hormonal contraception. 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
研究组 & 干预措施
Phase 1a: JNJ-63723283 (Monotherapy)
Experimental
Participants will receive monotherapy of JNJ-63723283 intravenously. The subsequent dose levels of JNJ-63723283 will be escalated using Bayesian logistic regression model (BLRM).
干预措施: JNJ-63723283 (Drug)
Phase 1b: Erdafitinib Combination
Experimental
Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM.
干预措施: JNJ-63723283 (Drug)
Phase 1b: Erdafitinib Combination
Experimental
Participants will receive erdafitinib in combination with JNJ-63723283 which will be escalated using BLRM.
干预措施: Erdafitinib (Drug)
结局指标
主要结局
Phase 1a and Phase 1b: Number of Participants with Dose Limiting Toxicity (DLT)
时间窗: Up to 6 weeks (maximum)
The DLTs are based on drug-related adverse events and defined as any of the following events: Infusion-related reactions, non-hematologic toxicity of Grade 3 or higher, or certain hematologic toxicity.
Phase 1a and Phase 1b: 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)
Severity of DLT will be graded by using NCI-CTCAE, version 4.03. Severity scale ranges from Grade 1 to Grade 5 with Grades as follows: Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Life-threatening), and Grade 5 (Death).
次要结局
- Phase 1b: Number of Participants with Adverse Events and Immune-Related Adverse Event (irAE) by Severity(Approximately up to 3 years)
- Phase 1a and Phase 1b: Number of Participants With Clinically Significant Changes in Vital Signs as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Phase 1a and Phase 1b: Number of Participants With Clinical Laboratory Abnormalities as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Phase 1a and Phase 1b: Number of Participants With ECG Abnormalities as a Measure of Safety and Tolerability(Approximately up to 3 years)
- Phase 1a and Phase 1b: Maximum Serum Concentration (Cmax) of JNJ-63723283(Approximately up to 3 years)
- Phase 1a and Phase 1b: Serum Concentration Immediately Prior to the Next Drug Administration (Ctrough) of JNJ-63723283(Approximately up to 3 years)
- Phase 1a and Phase 1b: Time to reach Maximum Observed serum Concentration (Tmax) of JNJ-63723283(Approximately up to 3 years)
- Phase 1a and Phase 1b: 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)
- Phase 1a and Phase 1b: Elimination Half-Life (t1/2) of JNJ-63723283(Approximately up to 3 years)
- Phase 1a and Phase 1b: Total Systemic Clearance (CL) of JNJ-63723283(Approximately up to 3 years)
- Phase 1a and Phase 1b: Volume of Distribution at Steady-State (Vss) of JNJ-63723283(Approximately up to 3 years)
- Phase 1b: Cmax of Erdafitinib(Approximately up to 3 years)
- Phase 1b: Ctrough of Erdafitinib(Approximately up to 3 years)
- Phase 1a and Phase 1b: Number of Participants With Anti-JNJ 63723283 Antibodies(Approximately up to 3 years)
研究者
研究点 (2)
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