NCT07545811招募中1 期
A Phase 1 Open-Label, Multicenter Study of JANX014 in Participants With Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 43
- 试验地点
- 7
- 主要终点
- Incidence of adverse events (AE) and Serious Adverse Events (SAE)
研究概览
简要总结
This study is a first-in-human, Phase 1, open-label, multicenter study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and the preliminary efficacy of JANX014 in adults with metastatic castration-resistant prostate cancer (mCRPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥18 years of age at the time of signing informed consent
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •For Dose Escalation: Having mCRPC that progressed after at least one novel anti-androgen therapy and at least one taxane containing regimen. Participants who have actively refused a taxane containing regimen or are medically unsuitable to receive taxane are eligible.
- •Adequate organ function
- •For Dose Expansion Part: Have received ≤ 2 anti-androgen therapies in either the HSPC or CRPC setting and no more than 1 prior taxane regimen in the HSPC setting. Participants who have actively refused a taxane regimen or are medically unsuitable to receive taxane are eligible.
排除标准
- •Prior solid organ transplant
- •Prior treatment with any CAR-T cell therapy, approved or investigational T-cell engager therapy, and prior receipt of radioligand therapy
- •Clinically significant cardiovascular disease
研究组 & 干预措施
Dose Expansion
Experimental
Participants will be dosed at levels previously declared tolerable.
干预措施: JANX014 (Biological)
Dose Escalation
Experimental
JANX014 will be administered at increasing dose levels per cohort to determine the maximum tolerated dose.
干预措施: JANX014 (Biological)
结局指标
主要结局
Incidence of adverse events (AE) and Serious Adverse Events (SAE)
时间窗: 2 years
Incidence of Dose Limiting Toxicities (DLTs)
时间窗: 2 years
次要结局
- Area under the curve from time 0 to t of JANX014 (AUC0-t)(up to 2 years)
- Maximum observed concentration of JANX014 (Cmax)(up to 2 years)
- Number of participants who develop anti-drug antibodies against JANX014(up to 2 years)
- Prostate Specific Antigen (PSA) response(up to 2 years)
- Overall Response Rate(up to 2 years)
- Duration of Response(up to 2 years)
- Radiographic Progression Free Survival (rPFS)(up to 2 years)
研究者
研究点 (7)
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