A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 17
- 主要终点
- Number of participants with dose limiting toxicities (DLTs)
研究概览
简要总结
This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a monotherapy in mCRPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT).
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
- •Progression on ADT and >=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane based chemotherapy regimens.
排除标准
- •Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.
- •Impaired cardiac function or clinically significant cardiac disease.
- •Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.
- •Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Participants receiving GSK5471713
Participants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.
干预措施: GSK5471713 (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities (DLTs)
时间窗: 28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
时间窗: Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
时间窗: Approximately 45 months
Number of participants with AEs leading to dose modifications
时间窗: Approximately 45 months
次要结局
- Time to maximum plasma concentration (Tmax) of GSK5471713(Approximately 45 months)
- Prostate-specific Antigen Decrease from Baseline >=50% (PSA50) Response Rate(Approximately 45 months)
- Maximum plasma concentration (Cmax) of GSK5471713(Approximately 45 months)
- Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713(Approximately 45 months)
- Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment(Approximately 45 months)