2025-523874-17-00招募中2 期
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).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Number of participants with dose limiting toxicities (DLTs) at each dose level
研究概览
简要总结
To evaluate the safety and tolerability of GSK5471713 in participants with mCRPC and to select 2 or more doses of GSK5471713 to implement in Part 2.
研究设计
- 分配方式
- Non Randomized
- 主要目的
- Part 2: Dose Optimization
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male participants ≥18 years of age
- •Participants with metastatic castration resistant prostate cancer (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) or post bilateral orchiectomy
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •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
- •Serum testosterone level <50 ng/dL (1.7 nmol/L) during the screening period. Participants must have undergone bilateral orchiectomy or be on continuous ADT for at least 4 weeks prior to first study dose and treatment must be continued throughout the study
- •Have adequate organ function
排除标准
- •Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma
- •Any history of prior transplant
- •Actively taking any medication known to increase the risk of QT interval prolongation or torsade de pointes
- •Known sensitivity to study intervention components or excipients or history of severe drug allergies or severe post-treatment hypersensitivity reactions
- •Prior PSMA radionuclide therapy within 2 months prior to first dose
- •Prior anticancer treatments within 4 weeks prior to the first dose.
- •Prior therapy with androgen receptor (AR) Degrader targeted therapy
- •Abnormal, or history of abnormal, adrenal function or have an illness or are taking medications known to affect adrenal gland function.
- •Any current or history of a significant liver condition, or clinically significant liver-related infection of laboratory abnormality.
- •Any active renal conditions
- •Untreated brain or CNS metastases or brain/CNS metastases that have progressed
- •Any clinically significant gastrointestinal abnormalities
- •Impaired cardiac function or clinically significant cardiac disease
- •Major surgery within 4 weeks prior to first dose
- •Diagnosis or history of invasive malignancy within the last 5 years, other than the disease under study
- •Serious infections within 4 weeks prior to the first dose
- •Ongoing adverse reaction(s) from prior therapy that have not recovered to ≤Grade 1 or to the baseline
- •Active or significant chronic respiratory diseases
研究组 & 干预措施
null, null, null
Test
干预措施: null, null, null (Drug)
结局指标
主要结局
Number of participants with dose limiting toxicities (DLTs) at each dose level
Number of participants with dose limiting toxicities (DLTs) at each dose level
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications
Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications
Severity of adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications
Severity of adverse events (AEs), serious adverse events (SAEs) and AEs leading to dose modifications
次要结局
- Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713
- Maximum plasma concentration (Cmax) of GSK5471713
- Time to maximum plasma concentration (tmax) of GSK5471713
- Prostate-specific antigen decrease from baseline >=50% (PSA50) response rate
- Objective response rate (ORR) per Prostate Cancer Working Group 3 (PCWG3) by investigator assessment
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (8)
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