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 June 26, 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
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
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported