NCT07592910尚未招募2 期
A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)
Prostate Cancer Clinical Trials Consortium0 个研究点目标入组 60 人开始时间: 2026年8月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
The purpose of this study is to find out whether mevrometostat in combination with enzalutamide delays cancer progression in people with metastatic castration-resistant prostate cancer (mCRPC) who have previously received enzalutamide, darolutamide, or apalutamide in the metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) setting but have not previously progressed on abiraterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Willing and able to provide written informed consent
- •Age 18 years or older
- •Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features
- •Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study
- •Cancer has spread to bone or soft tissue (metastatic disease), confirmed by imaging
- •ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours)
- •Testosterone level less than 50 ng/dL at screening, with ongoing hormone deprivation therapy or prior surgical castration
- •If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks
- •Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesions
- •Adequate organ function based on blood tests within 28 days of starting treatment, including adequate blood counts, kidney function, and liver function
- •Willing to use acceptable birth control during the study and for 30 days after the last dose
排除标准
- •History of myelodysplastic syndrome, acute myeloid leukemia, or other prior cancer (exceptions: non-melanoma skin cancer, carcinoma in situ, cancers more than 3 years ago with no recurrence, or early-stage cancers with low risk of recurrence)
- •Any medical or psychiatric condition, including active infection or recent suicidal ideation, that may make study participation unsafe
- •History of seizure or conditions that may increase seizure risk (e.g., prior stroke, significant brain trauma), or loss of consciousness or transient ischemic attack within 12 months
- •Untreated brain metastases, spinal cord compression, or clinically significant epidural disease
- •Use of 5-alpha reductase inhibitors, herbal medications, or supplements known to alter PSA levels within 4 weeks of starting treatment
- •AIDS-related illness or active hepatitis B or C (well-controlled HIV is allowed)
- •Known history of chronic liver disease (e.g., alcoholic liver disease, primary biliary cirrhosis, autoimmune hepatitis, Wilson's disease, hemochromatosis)
- •Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or prior gastric resection or lap-band surgery
- •Clinically significant cardiovascular disease within the past 6 months (e.g., heart attack, unstable angina, stroke, heart failure NYHA Class III/IV, pulmonary embolism, significant arrhythmias), cardiac pacemaker, or QTcF greater than 480 msec on screening ECG
- •Prior or current use of PARP inhibitors and/or AKT inhibitors
- •Prior cancer progression on abiraterone (stopping abiraterone due to side effects is allowed)
- •Known allergy to any study drug
- •Blood transfusion within 28 days prior to screening blood tests
- •Use of another investigational drug within 4 weeks before starting study treatment
- •Any other condition that, in the opinion of the investigator, would prevent safe participation
- •Current use or anticipated need for strong CYP3A4/5 inhibitors or inducers (other than enzalutamide) within 10 days or 5 half-lives prior to treatment start
研究者
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