2025-523672-23-00招募中2 期
A phase 2 trial of BMS-986365 in mCSPC patients with suboptimal PSA-response after 7 months of Androgen Deprivation Therapy (ADT) plus Androgen Receptor Pathway Inhibition (ARPI).
UroTrials GmbH, AIO-Studien gGmbH16 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年5月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 16
- 主要终点
- Confirmed PSA 50% response rate
研究概览
简要总结
Primary objective of this phase II trial is to explore the efficacy of an ARPI to BMS-986365 switch in participants with suboptimal 7-months (±4 weeks) PSA response despite combined ADT + ARPI-treatment for mCSPC with PSA response-rate as primary endpoint.
研究设计
- 分配方式
- Na
- 主要目的
- Single Arm
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult males of at least 18 years with signed written consent
- •Participants with documented metastatic castration sensitive prostate cancer
- •Detectable PSA (PSA ≥0.2 ng/ml) 7 months (± 4 weeks) after start ofanti-hormonal treatment initiation (ADT and/or ARPI, whatever was applied first)
- •Ongoing treatment with ADT and one of the following ARPIs: Abiraterone (plus Prednisone/Prednisolone), Apalutamide, Darolutamide (± Docetaxel), Enzalutamide
- •Minimum prior ARPI treatment duration of 4 months until registration
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Asymptomatic or symptomatic from metastatic prostate cancer based on BPI-SF score but must be stable with regard to BPI-SF score and pain medication, the later for at least 4 weeks prior to registration
- •Adequate blood count, liver and renal function
排除标准
- •Participants with predominant neuroendocrine prostate cancer (>50 %)
- •Participants with any liver metastasis
- •Participant has impaired cardiac function or clinically significant cardiac disease
- •Participants with any brain metastasis
- •Patients with 7-months PSA response < 0.2 ng/ml
研究组 & 干预措施
BMS-986365
Test
干预措施: BMS-986365 (Drug)
结局指标
主要结局
Confirmed PSA 50% response rate
Confirmed PSA 50% response rate
次要结局
- Time to symptomatic skeletal related event (TTSSE)
- Time to initiation of the first subsequent systemic therapy (TFST)
- ctDNA detection rate at baseline
- Changes in ctDNA from baseline during treatment
- Time to pain progression (TTPP)
- Confirmed PSA 30 % and 90% response rate
- Confirmed absolute PSA response rates (PSA ≤0.02, >0.02 – <0.2, ≥0.2-4.0 and >4.0 ng/ml)
- Time to PSA progression
- Time to mCRPC
- rPFS
- The incidence of treatment emergent AEs (according to NCI-CTC AE 5.0), SAEs, AEs leading to dose modifications, interruptions, and discontinuation, ECG findings, and laboratory abnormalities and changes from baseline (including clinical chemistry and hematology parameters)
- Overall Survival
- Change from baseline in NCCN FACT FPSI-17 total and subscale scores
- Change from baseline in EQ-5D-5L
- Change from baseline in BPI-SF
- Analysis of AR copy number, splice variants and mutations at baseline
研究者
Dr. Andrea Rößler
Scientific
UroTrials GmbH
研究点 (16)
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