A Phase 1 Open-Label, Multicenter Study of JANX013 Combined With JANX007 in Participants With Metastatic Castration Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
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 JANX013 in combination with JANX007 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 participants ≥ 18 years of age at the time of signing informed consent
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •For Dose Escalation:
- •- Have received at least 1 novel ARPI (e.g., abiraterone acetate, enzalutamide, apalutamide, or darolutamide) in any setting and have received at least 1 taxane regimen (in any setting), or who are medically unsuitable or have actively refused treatment with a taxane regimen.
- •For Dose Expansion:
- •Must be in the first-line or second-line setting for mCRPC or metastatic androgen pathway modulation resistant disease and must have received 1 novel ARPI in any setting.
- •Adequate organ function
排除标准
- •Prior treatment with any chimeric antigen receptor (CAR) T-cell therapy, any approved or investigational TCE, or any T-cell costimulatory agent
- •Clinically significant cardiovascular disease
- •Prior solid organ transplant
研究组 & 干预措施
Dose Escalation
Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
干预措施: JANX013 (Drug)
Dose Escalation
Participants receive JANX013 in combination with JANX007 administered at increasing dose levels per cohort
干预措施: JANX007 (Drug)
Dose Expansion
Participants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.
干预措施: JANX013 (Drug)
Dose Expansion
Participants receive JANX013 in combination with JANX007. Participants will be dosed at levels previously declared tolerable.
干预措施: JANX007 (Drug)
结局指标
主要结局
Incidence of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
时间窗: 2 years
Incidence of cytokine release syndrome (CRS)
时间窗: 2 years
Cytokine release syndrome (CRS) assessed according to ASTCT criteria.
次要结局
- Area under the curve from 0 to t of JANX013 and JANX007(Up to 2 years)
- Maximum observed concentration of JANX013 and JANX007(Up to 2 years)
- Time to maximum concentration of JANX013 and JANX007(Up to 2 years)
- Number of participants who develop anti-drug antibodies (ADAs) against JANX013 and JANX007(Up to 2 years)
- Prostate-specific antigen (PSA) response(Up to 2 years)
- Radiographic progression-free survival (rPFS)(Up to 2 years)
- Duration of response (DOR)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)