2024-517423-40-00招募中3 期
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate Prostate01)
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 508
- 试验地点
- 85
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
-
To compare Ifinatamab deruxtecan (I-DXd) to docetaxel with respect to overall survival (OS) in participants with mCRPC.
-
To compare I-DXd to docetaxel with respect to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
- •Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
- •Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
- •Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
- •Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
- •Has recovered from adverse events (AEs) due to previous anticancer therapies
排除标准
- •Is unable to swallow tablets/capsules
- •Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis
- •Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- •Has uncontrolled or significant cardiovascular disease
- •Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
- •Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
- •Has a “superscan” bone scan
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
Radiographic progression-free survival (rPFS)
Radiographic progression-free survival (rPFS)
次要结局
- Time to first subsequent therapy (TFST)
- Objective response rate (ORR)
- Duration of Response (DOR)
- Time to pain progression (TTPP)
- Time to prostate-specific antigen (PSA) progression
- PSA response rate
- Time to first symptomatic skeletal-related events (SSRE)
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Jelena Todoric
Scientific
Merck Sharp & Dohme LLC
研究点 (85)
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