A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) (Himalayas-1)
2026年9月2日 更新者：ORIC Pharmaceuticals
A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)
Himalayas-1 is a randomized, open-label, global, multicenter phase 3 study evaluating whether the combination of rinzimetostat with darolutamide is more effective compared to physician's choice of control; ARPI (darolutamide or enzalutamide) or docetaxel for treating patients with metastatic castration resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate.
The primary objective of this study is to demonstrate superiority in radiographic progression free survival (rPFS) of the investigational arm of rinzimetostat + darolutamide combination versus physician's choice of control: ARPI (darolutamide or enzalutamide) or docetaxel.
研究概览
研究类型
介入性
注册 (估计的)
600
阶段
- 第三阶段
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：ORIC Clinical Call Center
- 邮箱：clinical@oricpharma.com
学习地点
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Indiana
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Jeffersonville、Indiana、美国、40207
- 招聘中
- First Urology PSC
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North Carolina
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Charlotte、North Carolina、美国、29464
- 招聘中
- Urology Specialists of the Carolinas - University Place
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首席研究员：
- Jeremy Hubbard, MD
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Ohio
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Canton、Ohio、美国、44718
- 招聘中
- Gabrail Cancer Center Research
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Texas
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Dallas、Texas、美国、75231
- 招聘中
- Urology Clinics of North Texas
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Fort Worth、Texas、美国、76132
- 招聘中
- Urology Partners of North Texas (UPNT)
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Houston、Texas、美国、77027
- 招聘中
- Houston Metro Urology (HMU)
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Utah
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Murray、Utah、美国、84107
- 招聘中
- Summit Urology
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首席研究员：
- Stewart Landau, MD
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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:
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features
- Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first line mCRPC setting is required
- Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function
Exclusion Criteria:
Prior treatment for prostate cancer at any stage with cytotoxic chemotherapy, radioligand therapy (ie, 177Lu -PSMA-617, radium-223), ARPIs including apalutamide, darolutamide, and enzalutamide, PARP monotherapy or other systemic anticancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene or cell therapy, angiogenesis inhibitors, CDK4/6 inhibitors, PRC2 inhibitors) with the following exceptions:
- Treatment with first-generation antiandrogen agents (eg, bicalutamide, flutamide, nilutamide), but must be discontinued prior to the first dose of study medication
- Docetaxel treatment is allowed for mCSPC, as long as no signs of failure or disease progression occurred during treatment or within 3 months of treatment completion
- Any other anticancer therapy (drug or vaccine which does not meet exclusion criterion 1 above) within 28 days or 5 half-lives (whichever is longer) prior to randomization
- Known or suspected brain metastasis or active leptomeningeal disease
- Clinically significant cardiovascular disease defined as:
- Any medical (including active or clinically significant bacterial, fungal, or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the patient inappropriate for the study
- Active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery are excluded
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：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Investigational Arm
Rinzimetostat + darolutamide
|
400 mg once daily (QD)
其他名称：
600 mg twice daily (BID)
其他名称：
|
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有源比较器：Physician's Choice
Control Arm
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600 mg twice daily (BID)
其他名称：
160 mg once daily (QD)
其他名称：
75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
大体时间：Randomization up to ~2 years
|
Radiographic Progression Free Survival is defined as the time from the date of randomization to first evidence of radiographic progression as assessed in soft tissue by RECIST 1.1 or in bone per PCWG3 guideline by BICR, or death, whichever occurs first
|
Randomization up to ~2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：5 years
|
OS is defined as time from date of randomization to date of death due to any cause
|
5 years
|
|
Objective response rate (ORR)
大体时间：Randomization up to ~2 years
|
ORR is defined as proportion of patients with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR)
|
Randomization up to ~2 years
|
|
Duration of Response (DoR)
大体时间：Randomization up to ~2 years
|
DOR is defined as time of first response to first documentation of radiographic progression or death, whichever occurs first
|
Randomization up to ~2 years
|
|
Prostate Specific Antigen (PSA) response
大体时间：Randomization up to ~2 years
|
Defined as the proportion of patients with a confirmed ≥50% and ≥90% decline in PSA from baseline as per the PCWG3 criteria, along with the maximum decline in PSA occurring at any point on study
|
Randomization up to ~2 years
|
|
Time to PSA progression
大体时间：Randomization up to ~2 years
|
Measured from the start of treatment until criteria for PSA progression are met as per PCWG3
|
Randomization up to ~2 years
|
|
Time to initiation of antineoplastic therapy
大体时间：Randomization up to ~4 years
|
Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first)
|
Randomization up to ~4 years
|
|
Time to first symptomatic skeletal event
大体时间：Randomization up to ~4 years
|
Time from randomization to first symptomatic skeletal event (symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first) Compare patient reported outcomes (PROs) between the investigational treatment and control arms
|
Randomization up to ~4 years
|
|
Change from baseline in patient reported pain symptoms per Brief Pain Inventory-Short Form (BPI-SF)
大体时间：Randomization up to ~4 years
|
Analysis of Brief Pain Inventory-Short Form (BPI-SF) will be based on the pain severity score (mean of individual BPI-SF items 3, 4, 5 and 6), the pain interference score (the mean of items 9A-9G), and the single BPI-SF Item 3 which asks the patient to rate pain at its worst in the last 24 hours
|
Randomization up to ~4 years
|
|
Change from baseline in health-related quality of life (HRQoL) per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
大体时间：Randomization up to ~4 years
|
Change from baseline in HRQoL (FACT-P total score) will be presented.
The FACT-P total score will be calculated based on the participant responses to the 39 items in the FACT-P questionnaire.
Each item is rated on a 0 to 4 Likert-type scale and then combined to produce the FACT-P total score (0-156), with higher scores representing better health-related quality of life
|
Randomization up to ~4 years
|
|
Change from baseline in social/family well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
大体时间：Randomization up to ~4 years
|
Change from baseline in social/family well-being score will be presented.
The social/family well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28.
Each item is rated on a 0 to 4 Likert-type scale
|
Randomization up to ~4 years
|
|
Change from baseline in functioning well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
大体时间：Randomization up to ~4 years
|
Change from baseline in functioning well-being score will be presented.
The functioning well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28.
Each item is rated on a 0 to 4 Likert-type scale
|
Randomization up to ~4 years
|
|
Change from baseline in physical well-being per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
大体时间：Randomization up to ~4 years
|
Change from baseline in physical well-being score will be presented.
The physical well-being score will be calculated based on 7 items in the FACT-P questionnaire; score range 0-28.
Each item is rated on a 0 to 4 Likert-type scale
|
Randomization up to ~4 years
|
|
Change from baseline in symptoms per Functional Assessment of Cancer Therapy - Prostate (FACT-P)
大体时间：Randomization up to ~4 years
|
Change from baseline prostate cancer symptoms (PCS) score will be presented.
The PCS score will be calculated based on 12 items in the FACT-P questionnaire; score range 0-48.
Each item is rated on a 0 to 4 Likert-type scale
|
Randomization up to ~4 years
|
|
Change from baseline in patient reported health status per European Quality of Life 5-Dimension 5 Level (EQ-5D-5L)
大体时间：Randomization up to ~4 years
|
Participants will self-rate their current state of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression by choosing 1 of 5 possible responses that record the level of severity (no problems, slight problems, moderate problems, severe problems, or extreme problems) within each dimension.
The questionnaire also includes a visual analog scale to self-rate general health state on a scale from "the worst health you can imagine" to "the best health you can imagine."
|
Randomization up to ~4 years
|
|
Symptomatic toxicity as measured by items from the Patient-Reported Outcome CTCAE (PRO-CTCAE)
大体时间：Randomization up to ~2 years
|
Each selected PRO-CTCAE items will be assessed related to one or more attributes that include counts for the frequency, severity, and/or interference with usual or daily activities
|
Randomization up to ~2 years
|
|
Overall side effect burden as measured by the FACT- GP5
大体时间：Randomization up to ~2 years
|
The FACT-GP5 question assesses overall side effect burden with the following response options "I am bothered by side effects of treatment," is rated on a 5-point scale ranging from "not at all" (0) to "very much" (4) and counts will be presented
|
Randomization up to ~2 years
|
|
Time to confirmatory deterioration in patient-reported pain symptoms per BPI-SF Item 3 "worst pain in 24 hours"
大体时间：Randomization up to ~4 years
|
Defined as the time from randomization to onset of pain progression, which is defined as > 2-point increase from baseline in the score from the BPI-SF Question 3 that is confirmed at the next consecutive assessment > 4 weeks apart or an initial deterioration followed by death before the next assessment
|
Randomization up to ~4 years
|
|
Time to definitive deterioration in patient-reported health related quality of life (HRQoL) per FACT-P
大体时间：Randomization up to ~4 years
|
Defined as the time from randomization to onset of definitive deterioration in FACT-P total score, which is defined as >10 point decrease from baseline and no subsequent observations with a <10 point decrease from baseline FACT-P total score
|
Randomization up to ~4 years
|
|
Time to definitive deterioration in patient-reported physical well-being per FACT-P
大体时间：Randomization up to ~4 years
|
Time to definitive deterioration in physical well-being (PWB) per FACT-P is defined as the time from randomization to onset of definitive deterioration in physical well-being, which is defined as ≥3-point
|
Randomization up to ~4 years
|
|
Incidence of Adverse Events (AEs)
大体时间：Randomization up to ~2 years
|
Type, incidence, relationship to study treatments, severity, and seriousness of AEs [as graded by National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v6.0] and other clinical assessments
|
Randomization up to ~2 years
|
|
Evaluate the pharmacokinetics (PK) of rinzimetostat in combination with darolutamide
大体时间：Randomization up to ~1 year
|
Rinzimetostat characterized by predose and postdose plasma concentrations at selected time points
|
Randomization up to ~1 year
|
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。
合作者
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8月3日
初级完成 (估计的)
2028年3月1日
研究完成 (估计的)
2030年9月1日
研究注册日期
首次提交
2026年6月18日
首先提交符合 QC 标准的
2026年7月20日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
关键字
- 安全
- 前列腺癌
- 开放标签
- 功效
- 恩杂鲁胺
- 阿比特龙
- 复发
- 耐火
- 晚期前列腺癌
- 多烯紫杉醇
- 激素抵抗
- 醋酸阿比特龙
- 达洛鲁胺
- 转移性去势抵抗性前列腺癌 (mCRPC)
- hormone dependent malignancy
- androgen receptor (AR) signaling
- androgen pathway modulator-resistant (APMR)
- metastatic castration sensitive prostate cancer (mCSPC)
- androgen pathway modulator-naïve/sensitive (APMN/S)
- polycomb repressive complex 2 (PRC2)-controlled dysregulation
- embryonic ectoderm development (EED)
- enhancer of zeste homolog 2 (EZH2)
- ORIC-944
- rinzimetostat
- mevrometostat
其他相关的 MeSH 术语
其他研究编号
- ORIC-944-05
- 2026-525340-15-00 (克蒂斯)
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
在美国制造并从美国出口的产品
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.