NCT07719361招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111
研究概览
简要总结
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
- •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.
排除标准
- •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.
研究组 & 干预措施
FX-111 Dose Level 5
Experimental
干预措施: FX-111 (Drug)
FX-111 Dose Level 1
Experimental
干预措施: FX-111 (Drug)
FX-111 Dose Level 2
Experimental
干预措施: FX-111 (Drug)
FX-111 Dose Level 3
Experimental
干预措施: FX-111 (Drug)
FX-111 Dose Level 4
Experimental
干预措施: FX-111 (Drug)
结局指标
主要结局
The number of adverse events (AEs), serious adverse events (SAEs), and drug withdrawal due to AE in participants receiving FX-111
时间窗: Study day 1 throughout the study, estimated to be 6 months.
次要结局
- Maximum concentration (Cmax) of FX-111 in the bloodstream.(Study day 1 throughout the study for 6 months.)
- Area Under the Concentration Time Curve(Study day 1 throughout the study for 6 months.)
- Time required (Tmax) to reach Cmax of FX-111 in the bloodstream.(Study day 1 throughout the study for 6 months.)
- Rate of confirmed prostate-specific antigen (PSA) decline of ≥ 50% from baseline (PSA50).(Baseline and every 4 weeks throughout the study, estimated to be 6 months.)
- Objective Response Rate (ORR)(Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.)
- Duration of Response (DoR)(Tumor assessments at baseline and every 8 weeks throughout the study, estimated to be 6 months.)
研究者
研究点 (12)
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