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A Study in Patients With Metastatic Castration-Resistant Prostate Cancer

2026年7月31日 更新者：Flare Therapeutics Inc.

A Phase 1, First-in-Human, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FX-111 in Patients With Metastatic Castration-Resistant Prostate Cancer

The goal of this clinical trial is to find out if FX-111 is safe enough to permit further studies in adult male participants with metastatic castration-resistant prostate cancer (mCRPC). It will also study the drug's pharmacokinetics (how the body breaks down FX-111) and how well FX-111 treats mCRPC. The main questions it aims to answer are:

What are the side effects of FX-111?

Does FX-111 work to reduce or prevent progression of mCRPC?

The study doctor will oversee participants' treatment with FX-111 and ask about any side effects. Participants will take FX-111 every day by mouth and will have regular physical and laboratory examinations to check health and tumor status.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Janine Koucheki, Associate Director, Clinical Operations
  • 电话号码：857-706-4400
  • 邮箱：clinops@flaretx.com

研究联系人备份

  • 姓名：Carolyn McCrone, Sr Clinical Trial Associate
  • 电话号码：857-706-4400
  • 邮箱：clinops@flaretx.com

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90025
        • 招聘中
        • START Los Angeles
        • 接触：
        • 首席研究员：
          • Navid Hafez, MD, MPH
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 尚未招聘
        • Massachusetts General Hospital
        • 首席研究员：
          • Xin Gao, MD
    • Michigan
      • Grand Rapids、Michigan、美国、49546
        • 招聘中
        • START MidWest
        • 首席研究员：
          • Emerson Lim, MD
        • 接触：
    • New Jersey
      • East Brunswick、New Jersey、美国、08816
        • 招聘中
        • START New Jersey
        • 首席研究员：
          • Bruno Fang, MD
        • 接触：
    • South Carolina
      • Myrtle Beach、South Carolina、美国、29572
    • Tennessee
      • Nashville、Tennessee、美国、37203
        • 尚未招聘
        • Tennessee Oncology
        • 首席研究员：
          • Katy Beckermann, MD, Ph.D.
    • Texas
      • Fort Worth、Texas、美国、76104
        • 招聘中
        • START Dallas-Fort Worth
        • 接触：
        • 首席研究员：
          • Salwan Al Mutar, MD, M.Sc.
      • Houston、Texas、美国、77054
      • San Antonio、Texas、美国、78229
        • 招聘中
        • NEXT Oncology
        • 接触：
        • 首席研究员：
          • Ildefonso Ismael Rodriguez Rivera, MD
    • Virginia
      • Fairfax、Virginia、美国、22031
        • 招聘中
        • NEXT Virginia
        • 首席研究员：
          • Mohamad Salkeni, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Confirmed adenocarcinoma of the prostate.
  • PSA levels ≥ 2 ng/mL at screening visit.
  • Progressing PSA, defined as two consecutive increases in the most recent PSA measurements taken at least 1 week apart.
  • Progressed on Androgen Deprivation Therapy (ADT) and at least one prior potent Androgen Receptor (AR) pathway inhibitor given in castration-sensitive prostate cancer setting or approved for castration-resistant prostate cancer (eg, apalutamide, darolutamide, abiraterone, enzalutamide).
  • Ongoing primary ADT with gonadotropin-releasing hormone agonist or antagonist in the absence of bilateral orchiectomy.
  • Acceptable physical functioning and laboratory measurements, per the study protocol.
  • Discontinued prior therapies within protocol-specified timeframes.
  • Commit to use of highly-effective contraception while on study and for 90 days after.
  • Willing and able to adhere to the study visit schedule and other protocol defined requirements.

Exclusion Criteria:

  • Predominance of small cell carcinoma of the prostate/neuroendocrine prostate cancer in most recent tumor biopsy.
  • Participants with brain metastases that require ongoing treatment with radiation or high-dose steroids.
  • Not recovered from side effects of prior surgery or cancer treatments.
  • Evidence of active viral, bacterial, or fungal infection requiring treatment with antivirals, antibiotics, or anti-fungal medications.
  • Prior treatment with AR degraders and molecules with an AR ligand such as AR Regulated Induced Proximity Targeting Chimera (RIPTAC).
  • Blood clots ≤ 4 weeks prior to start of treatment.
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study drug. Patients may be eligible if the malignancy is clinically stable or has been treated with curative intent.
  • Any evidence of severe or uncontrolled systemic diseases.
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of the patient's safety or study results.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：FX-111 Dose Level 1
药品：FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
实验性的：FX-111 Dose Level 2
药品：FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
实验性的：FX-111 Dose Level 3
药品：FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
实验性的：FX-111 Dose Level 4
药品：FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.
实验性的：FX-111 Dose Level 5
药品：FX-111
FX-111 will be administered orally once daily in continuous 28-day cycles.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111
大体时间：Study day 1 throughout the study, estimated to be 6 months.
Study day 1 throughout the study, estimated to be 6 months.

次要结果测量

结果测量
措施说明
大体时间
Area Under the Concentration Time Curve
大体时间：Study day 1 throughout the study for 6 months.
Total body exposure of FX-111
Study day 1 throughout the study for 6 months.
Maximum concentration (Cmax) of FX-111 in the bloodstream.
大体时间：Study day 1 throughout the study for 6 months.
Study day 1 throughout the study for 6 months.
Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.
大体时间：Study day 1 throughout the study for 6 months.
Study day 1 throughout the study for 6 months.
Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50).
大体时间：Baseline and every 4 weeks throughout the study, estimated to be 6 months.
Baseline and every 4 weeks throughout the study, estimated to be 6 months.
Objective Response Rate (ORR)
大体时间：Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.

The number of patients who achieve either a Complete Response (CR) or Partial Response (PR) to FX-111.

CR: disappearance of all lesions and pathologic lymph nodes. PR: ≥30% decrease in sum of lesions, no new lesions, no progression of non-target lesions.
Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
Duration of Response (DoR)
大体时间：Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.
DoR is the time from initial CR or PR until disease progression.
Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Flare Therapeutics Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月1日

初级完成 (估计的)

2028年2月15日

研究完成 (估计的)

2029年2月15日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年8月4日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • FX-111-CLINPRO-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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