NCT07567846招募中1 期
A Phase I/II Dose-escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Preliminary Activity of GDC-1261 in Patients With Advanced or Metastatic 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
- 260
- 试验地点
- 5
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-1261 in participants with advanced or metastatic prostate cancer. It's also to identify a recommended dose(s) and regimen for GDC-1261 for subsequent studies.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of <=1
- •Life expectancy is >= 3 months
- •Histologically or cytologically confirmed prostate adenocarcinoma
- •Disease progression during or following the direct prior line of therapy
- •Ongoing androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonist or antagonist, or have had bilateral orchiectomy
- •Metastatic disease
- •Adequate end organ function
排除标准
- •Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives
- •Structurally unstable bone lesions suggest an impending fracture
- •Untreated central nervous system (CNS) metastases or leptomeningeal disease
- •Uncontrolled pain
- •History of malignancy within 5 years
- •Infection requiring systemic IV antibiotics within 14 days or oral antibiotics within 7 days prior to screening, or any evidence of current infection
- •Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results
研究组 & 干预措施
Dose Escalation + Expansion
Experimental
Participants will receive GDC-1261 as per the schedule described in the protocol.
干预措施: GDC-1261 (Drug)
研究者
研究点 (5)
Loading locations...
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