Testing ifinatamab deruxtecan against docetaxel in advanced prostate cancer
Compares a study medicine with chemotherapy in men with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Key facts
- Where
- Beijing, Changchun, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Jiaxing, Jinan, Nanjing, Nanning, Ningbo, Shanghai, Taiyuan, Ürümqi, Wenzhou, Wuhan, Xi'an, Xuzhou, Zhengzhou, and Zhuhai, ChinaSee the 34 sites
- Phase
- Phase 3
Where in China
- Peking University First Hospital (Site 1434)Beijing, ChinaTaking people
- Shanghai General Hospital (Site 1449)Beijing, ChinaTaking people
- Jilin Province People's Hospital (Site 1461)Changchun, ChinaTaking people
- Hunan Cancer Hospital (Site 1411)Changsha, ChinaTaking people
- West China Hospital of Sichuan University (Site 1451)Chengdu, ChinaTaking people
- West China Hospital, Sichuan University (Site 1468)Chengdu, ChinaTaking people
- Chongqing University Three Gorges Hospital (Site 1405)Chongqing, ChinaTaking people
- The First Affiliated Hospital of Chonqing Medical University (Site 1406)Chongqing, ChinaTaking people
- The First Affiliated Hospital Of Fujian Medical University (Site 1452)Fuzhou, ChinaTaking people
- Guangzhou First People's Hospital (Site 1410)Guangzhou, ChinaTaking people
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University (Site 1402)Guangzhou, ChinaTaking people
- Sun Yat-sen University Cancer Center (Site 1409)Guangzhou, ChinaTaking people
- Sun Yat-Sen University Cancer Center (Site 1467)Guangzhou, ChinaTaking people
- Zhejiang Cancer Hospital (Site 1447)Hangzhou, ChinaTaking people
- The First Hospital of Jiaxing (Site 1416)Jiaxing, ChinaTaking people
- Shandong Cancer Hospital (Site 1421)Jinan, ChinaTaking people
- Jiangsu Province Hospital (Site 1426)Nanjing, ChinaTaking people
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School (Site 1425)Nanjing, ChinaTaking people
- Zhongda Hospital Southeast University (Site 1427)Nanjing, ChinaTaking people
- Guangxi Medical University Cancer Hospital (Site 1414)Nanning, ChinaTaking people
- The First Affiliated Hospital of Ningbo University (Site 1419)Ningbo, ChinaTaking people
- Fudan University Shanghai Cancer Center (Site 1400)Shanghai, ChinaTaking people
- Renji Hospital Shanghai Jiao Tong University School of Medicine (Site 1457)Shanghai, ChinaTaking people
- Shanghai Tenth People's Hospital (Site 1441)Shanghai, ChinaTaking people
- Shanghai Tongji Hospital (Site 1412)Shanghai, ChinaTaking people
- Zhongshan Hospital Fudan University (Site 1430)Shanghai, ChinaTaking people
- First Affiliated Hospital Of Shanxi Medical University (Site 1460)Taiyuan, ChinaTaking people
- The Affiliated Cancer Hospital of Xinjiang Medical University (Site 1469)Ürümqi, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical University (Site 1437)Wenzhou, ChinaTaking people
- Union Hospital Tongji Medical College Huazhong University of Science and Technology (Site 1424)Wuhan, ChinaTaking people
- The first affiliated Hospital of Xi an Jiaotong University (Site 1408)Xi'an, ChinaTaking people
- The Affiliated Hospital of Xuzhou Medical University (Site 1438)Xuzhou, ChinaTaking people
- Henan Cancer Hospital (Site 1472)Zhengzhou, ChinaTaking people
- The Fifth Affiliated Hospital of Sun Yat-Sen University (Site 1459)Zhuhai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06925737EU 2024-517423-40-00
- Record updated
- 30 October 2026
- Original description
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.Read full original descriptionShow less
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Inclusion: The main inclusion criteria include but are not limited to the following:; Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology; Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening; Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI); Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment; Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy; Has recovered from adverse events (AEs) due to previous anticancer therapies.
Exclusion: Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC); Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities; Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:; Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids; Has current ILD/pneumonitis; Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out; Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses; Has uncontrolled or significant cardiovascular disease; The main exclusion criteria include but are not limited to the following:; Is unable to swallow tablets/capsules; Has a "superscan" bone scan.