A Phase 1, Open-Label, Multicenter, Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 in Patients With Advanced or Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 50
- 主要终点
- Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary activity of RO7656594 in participants with advanced or metastatic prostate cancer. It will also identify recommended doses and regimens for RO7656594 for subsequent studies.
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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Metastatic prostate adenocarcinoma without small-cell carcinoma or neuroendocrine features.
- •Prior therapy with a second-generation androgen receptor (AR)-targeted therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
- •Prior therapy with a taxane regimen or are considered ineligible for treatment with a taxane regimen or have refused treatment with a taxane regimen, unless otherwise specified.
- •For participants with a known pathogenic breast cancer gene 1 (BRCA1) or BRCA2 mutation: prior therapy with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor, or are considered ineligible for treatment with a PARP inhibitor, if such therapy is approved and available.
排除标准
- •Treatment with any approved systemic anti-cancer therapy within 14 days or 5 drug elimination half-lives (whichever is longer, not to exceed 28 days) prior to the first study treatment.
- •Treatment with any investigational agent within 28 days prior to the first study treatment.
- •Treatment with any previous AR protein degrader.
- •Untreated central nervous system (CNS) metastases or leptomeningeal disease.
- •Note: Other protocol specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
Stage 2: Expansion
Participants will receive RO7656594 at or below the maximum tolerated dose (MTD) or maximum administered dose (MAD).
干预措施: RO7656594 (Drug)
Stage 1: Dose Escalation
Participants will receive RO7656594 administered at a specified dose on specific days in each 28-day cycle. The dose will be increased in successive cohorts until a study-specific threshold is reached.
干预措施: RO7656594 (Drug)
结局指标
主要结局
Percentage of Participants Who Experience Dose-limiting Toxicities (DLTs)
时间窗: Days 1-28 of Cycle 1
Percentage of Participants with Adverse Events
时间窗: From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days)
次要结局
- Prostate-Specific Antigen-50% (PSA50) Response Rate of RO7656594(From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days))
- Plasma Concentration of RO7656594(Multiple timepoints from Cycle 1 Day 1 up to approximately 12 months (1 cycle= 28 days))
- Prostate-Specific Antigen-30% (PSA30) Response Rate of RO7656594(From Cycle 1 Day 1 until 28 days after the final dose (Up to approximately 24 months) (1 cycle= 28 days))