A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Launched by MERCK SHARP & DOHME LLC · Apr 7, 2025
Trial Information
Current as of November 04, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC), a type of cancer that has spread and is no longer responding to standard hormone treatments. The main goal of the study is to find out if I-DXd can help patients live longer and manage their cancer better compared to traditional chemotherapy.
To participate in this trial, men aged 65 to 74 who have been diagnosed with mCRPC may be eligible, especially if their cancer has progressed after hormone therapy and they have previously tried specific cancer medications. However, individuals with certain health issues, such as severe lung problems or significant heart disease, would not be allowed to join. Participants in the study can expect to receive either the new treatment or standard chemotherapy and will be monitored closely by the research team throughout the trial. This study is important as it could lead to new options for treating this challenging form of prostate cancer.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- The main inclusion criteria include but are not limited to the following:
- • Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
- • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
- • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment
- Exclusion Criteria:
- The main exclusion criteria include but are not limited to the following:
- • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
- • Has uncontrolled or significant cardiovascular disease
- • Has received prior treatment with a taxane-based chemotherapy agent for mCRPC
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Melbourne, Victoria, Australia
Sapporo, Hokkaido, Japan
Santiago, Region M. De Santiago, Chile
New York, New York, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
Grand Rapids, Michigan, United States
Roanoke, Virginia, United States
Haifa, Israel
Ramat Gan, Israel
Dong Gu, Ulsan Kwangyokshi, Korea, Republic Of
Taiwan, Taipei, Taiwan
Tel Aviv, Israel
Seoul, Korea, Republic Of
Saint Louis Park, Minnesota, United States
Saint Paul, Minnesota, United States
Grand Island, Nebraska, United States
La Rioja, Argentina
Guatemala City, Guatemala
Guatemala, Guatemala
Petah Tikva, Israel
Sakai, Osaka, Japan
Kumamoto, Japan
Nagano, Japan
Guatemala, Guatemala
Songpagu, Seoul, Korea, Republic Of
Duarte, California, United States
Irvine, California, United States
La Jolla, California, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Dallas, Texas, United States
Mar Del Plata, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Caba, Argentina
Mendoza, Argentina
Salta, Argentina
San Juan, Argentina
Blacktown, New South Wales, Australia
Greenslopes, Queensland, Australia
Linz, Upper Austria, Austria
Wels, Upper Austria, Austria
São José Do Rio Preto, Brazil
Beijing, Beijing Municipality, China
Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
Guangzhou, Guangdong, China
Nanning, Guangxi, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Jinan, Shandong, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
ürümqi, Xinjiang, China
Ningbo, Zhejiang, China
Brno, Brno Mesto, Czechia
Prague, Czechia
Aalborg, North Denmark, Denmark
Vejle, Region Syddanmark, Denmark
Suresnes, Ain, France
Caen, Calvados, France
Besançon, Doubs, France
Limoges, Haute Vienne, France
Vandœuvre Lès Nancy, Meurthe Et Moselle, France
Rouen, Seine Maritime, France
Nürtingen, Baden Wurttemberg, Germany
Duisburg, North Rhine Westphalia, Germany
Lübeck, Schleswig Holstein, Germany
Berlin, Germany
Hamburg, Germany
Athens, Attica, Greece
Athens, Attica, Greece
Guatemala City, Guatemala
Guatemala City, Guatemala
Hong Kong, Hong Kong
New Territories, Hong Kong
Kfar Saba, Israel
ẕerifin, Israel
Rozzano, Milano, Italy
Rome, Roma, Italy
Arezzo, Italy
Bergamo, Italy
Verona, Italy
Nagoya, Aichi Ken, Japan
Sakura, Chiba, Japan
Kitakyushu, Fukuoka, Japan
Kurume, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Kobe, Japan
Kahoku Gun, Ishikawa Ken, Japan
Kamakura, Kanagawa, Japan
Yufu, Oita Prefecture, Japan
Ginowan, Okinawa, Japan
Koshigaya, Saitama, Japan
Ube, Yamaguchi, Japan
Chūō, Yamanashi, Japan
Fukuoka, Japan
Fukuoka, Japan
Gifu, Japan
Hiroshima, Japan
Tokushima, Japan
Nijmegen, Gelderland, Netherlands
Venlo, Limburg, Netherlands
Amsterdam, North Holland, Netherlands
Hilversum, North Holland, Netherlands
Hoofddorp, North Holland, Netherlands
Hengelo, Overijssel, Netherlands
The Hague, South Holland, Netherlands
Amersfoort, Utrecht, Netherlands
Nieuwegein, Utrecht, Netherlands
Lorenskog, Akershus, Norway
Gjøvik, Oppland, Norway
Trondheim, Sor Trondelag, Norway
Oslo, Norway
Poznan, Greater Poland Voivodeship, Poland
Bydgoszcz, Kuyavian Pomeranian Voivodeship, Poland
Krakow, Lesser Poland Voivodeship, Poland
Siedlce, Masovian Voivodeship, Poland
Katowice, Silesian Voivodeship, Poland
Cape Town, Gauteng, South Africa
Hwasun Gun, Jeonranamdo, South Korea
Seocho Gu, Seoul, South Korea
Songpagu, Seoul, South Korea
Donggu, Ulsan Kwangyokshi, South Korea
Seoul, South Korea
Seoul, South Korea
Santiago De Compostela, La Coruna, Spain
Majadahonda Madrid, Madrid, Spain
Madrid, Spain
Barcelona, Spain
Madrid, Spain
Seville, Spain
Stockholm, Stockholm County, Sweden
Aarau, Canton Of Aargau, Switzerland
Geneva, Canton Of Geneva, Switzerland
Zurich, Switzerland
Kaohsiung City, Taiwan
Taichung, Taiwan
Taipei, Taiwan
Los Angeles, California, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Williamsville, New York, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Macquarie University, New South Wales, Australia
Salzburg, Austria
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, Brazil
São Paulo, Brazil
Santiago, Region M. De Santiago, Chile
Chongqing, Chongqing Municipality, China
Chongqing, Chongqing Municipality, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Zhuhai, Guangdong, China
Changsha, Hunan, China
Nanjing, Jiangsu, China
Nanjing, Jiangsu, China
Xuzhou, Jiangsu, China
Changchun, Jilin, China
Xi'an, Shaanxi, China
Shanghai, Shanghai Municipality, China
Taiyuan, Shanxi, China
Chengdu, Sichuan, China
Chengdu, Sichuan, China
Hangzhou, Zhejiang, China
Jiaxing, Zhejiang, China
Wenzhou, Zhejiang, China
Herlev, Capital Region, Denmark
Odense, Region Syddanmark, Denmark
Marseille, Bouches Du Rhone, France
Nîmes, Gard, France
Paris, France
Munich, Bavaria, Germany
Nuremberg, Bavaria, Germany
Chaidari Athens, Attica, Greece
Kifissia, Attica, Greece
Marousi, Attica, Greece
Cork, Ireland
Dublin, Ireland
Milan, Lombardy, Italy
Foggia, Italy
Terni, Italy
Tōon, Ehime, Japan
Hamamatsu, Shizuoka, Japan
Minato, Tokyo, Japan
Shinjuku, Tokyo, Japan
Kagoshima, Japan
Kyoto, Japan
Niigata, Japan
Rotterdam, South Holland, Netherlands
Schiedam, South Holland, Netherlands
Groningen, Netherlands
Warsaw, Masovian Voivodeship, Poland
Singapore, Central Singapore, Singapore
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Santander, Cantabria, Spain
Barcelona, Spain
Córdoba, Spain
Lugo, Spain
Valencia, Spain
Malmo, Sweden
Stockholm, Stockholm County, Sweden
Uppsala, Sweden
Basel, Canton Of Basel City, Switzerland
Fribourg, Switzerland
Bangkoknoi, Bangkok, Thailand
Dusit, Bangkok, Thailand
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported