ACTRN12626000947303进行中(未招募)2 期
A Phase 2a Open-Label, Multicenter, First-in-Human Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDB-1829 in Combination with Enzalutamide in Participants with Metastatic Castration-Resistant Prostate Cancer(mCRPC)
Interdict Bio0 个研究点目标入组 6 人开始时间: 2027年4月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 6
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
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 No limit(—)
- 性别
- Male
入选标准
- •Age 18 or older
- •Confirmed diagnosis of prostate cancer (adenocarcinoma) that has spread to other parts of the body(metastatic disease)
- •Cancer has stopped responding to hormone therapy (castration-resistant prostate cancer, or mCRPC)
- •Currently on hormone therapy (androgen deprivation therapy) or has had surgical removal of thetesticles, with testosterone levels at or below 50 ng/dL
- •Cancer has gotten worse on or after the most recent treatment
- •Able to carry out normal daily activities with little or no physical limitation (ECOG performance status 0 or1)
- •Has not received any prior treatment for mCRPC
排除标准
- •Received chemotherapy, immunotherapy, targeted therapy, or another investigational cancer treatmentwithin 21 days before starting study treatment (or within 6 weeks for prior radiopharmaceutical therapysuch as lutetium-177 PSMA)
- •Received radiation therapy within 28 days before starting study treatment
- •Prostate cancer with small cell or neuroendocrine features on any prior or current biopsy
- •Stroke or mini-stroke (TIA) within the past 6 months
- •History of organ transplant
研究者
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