A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 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 Criteria: The main exclusion criteria include but are not limited to the following: * Is unable to swallow tablets/capsules * Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis: 1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids 2. Has current ILD/pneumonitis 3. 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 * 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 a "superscan" bone scan
Study sites (55)
AZ
- Mayo Clinic in Arizona - Phoenix ( Site 0044) · Phoenix, AZ 85054Study Coordinator · Study contact · 855-776-0015More trials in Phoenix
CA
- Community Cancer Institute ( Site 0081) · Clovis, CA 93611Study Coordinator · Study contact · 559-387-1600More trials in Clovis
- City of Hope Comprehensive Cancer Center ( Site 0049) · Duarte, CA 91010Study Coordinator · Study contact · 626-256-4673More trials in Duarte
- City of Hope Lennar Foundation Cancer Center ( Site 0059) · Irvine, CA 92618Study Coordinator · Study contact · 626-256-4673More trials in Irvine
- Moores Cancer Center ( Site 0010) · La Jolla, CA 92093Study Coordinator · Study contact · 858-822-6100More trials in La Jolla
- Veterans Affairs Long Beach Healthcare System ( Site 0058) · Long Beach, CA 90822Study Coordinator · Study contact · 562-826-8000More trials in Long Beach
- Cedars-Sinai Medical Center ( Site 0068) · Los Angeles, CA 90048Study Coordinator · Study contact · 310-423-7600More trials in Los Angeles
- UCLA Hematology/Oncology - Santa Monica ( Site 0002) · Los Angeles, CA 90404Study Coordinator · Study contact · 310-825-2631More trials in Los Angeles
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006) · Orange, CA 92868Study Coordinator · Study contact · 714-509-2371More trials in Orange
- Stanford Cancer Center ( Site 0046) · Palo Alto, CA 94304Study Coordinator · Study contact · 650-725-2078More trials in Palo Alto
CO
- Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053) · Aurora, CO 80045Study Coordinator · Study contact · 303-399-8020More trials in Aurora
CT
- Yale-New Haven Hospital-Yale Cancer Center ( Site 0050) · New Haven, CT 06510Study Coordinator · Study contact · 203-737-6087More trials in New Haven
- Veterans Affairs Connecticut Healthcare System ( Site 0062) · West Haven, CT 06516Study Coordinator · Study contact · 203-932-5711More trials in West Haven
DC
- The GW Medical Faculty Associates ( Site 0057) · Washington D.C., DC 20037More trials in Washington D.C.
- Washington DC Veterans Affairs Medical Center ( Site 0056) · Washington D.C., DC 20422Study Coordinator · Study contact · 202-745-8000More trials in Washington D.C.
FL
- Clermont Oncology Center ( Site 0087) · Clermont, FL 34711Study Coordinator · Study contact · 386-538-3169More trials in Clermont
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077) · Jacksonville, FL 32224Study Coordinator · Study contact · 855-776-0015More trials in Jacksonville
- Mid Florida Hematology and Oncology Center ( Site 0086) · Orange City, FL 32763Study Coordinator · Study contact · 386-774-1223More trials in Orange City
GA
- Emory University School of Medicine- Grady Campus ( Site 0103) · Atlanta, GA 30303Study Coordinator · Study contact · 404-727-6123More trials in Atlanta
- Winship Cancer Institute, Emory University ( Site 0003) · Atlanta, GA 30322Study Coordinator · Study contact · 404-778-4824More trials in Atlanta
IL
- Rush University Medical Center-Hematology and Oncology ( Site 0028) · Chicago, IL 60607Study Coordinator · Study contact · 312-563-2531More trials in Chicago
- University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063) · Chicago, IL 60612Study Coordinator · Study contact · 312-355-1625More trials in Chicago
KY
- University of Kentucky Chandler Medical Center ( Site 0048) · Lexington, KY 40536Study Coordinator · Study contact · 866-340-4488More trials in Lexington
MA
- Beth Israel Deaconess Medical Center ( Site 0043) · Boston, MA 02215Study Coordinator · Study contact · 617-667-2100More trials in Boston
- Dana Farber Cancer Institute ( Site 0012) · Boston, MA 02215Study Coordinator · Study contact · 617-632-6049More trials in Boston
MD
- Greenebaum Comprehensive Cancer Center ( Site 0021) · Baltimore, MD 21201Study Coordinator · Study contact · 410-707-4011More trials in Baltimore
MI
- University of Michigan ( Site 0005) · Ann Arbor, MI 48109Study Coordinator · Study contact · 734-647-8902More trials in Ann Arbor
- Henry Ford Hospital ( Site 0035) · Detroit, MI 48202Study Coordinator · Study contact · 313-725-7920More trials in Detroit
- Cancer and Hematology Centers of Western Michigan ( Site 0015) · Grand Rapids, MI 49503Study Coordinator · Study contact · 616-399-6500More trials in Grand Rapids
MN
- Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0078) · Rochester, MN 55905Study Coordinator · Study contact · 855-776-0015More trials in Rochester
- HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0032) · Saint Louis Park, MN 55426Study Coordinator · Study contact · 612-341-4800More trials in Saint Louis Park
- HealthPartners Cancer Center at Regions Hospital ( Site 0052) · Saint Paul, MN 55101Study Coordinator · Study contact · 612-341-4800More trials in Saint Paul
MT
- St. Vincent Frontier Cancer Center-Research ( Site 0037) · Billings, MT 59102Study Coordinator · Study contact · 406-238-6290More trials in Billings
NE
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island ( Site 0076) · Grand Island, NE 68803More trials in Grand Island
- Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026) · Omaha, NE 68130More trials in Omaha
NJ
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0016) · Hackensack, NJ 07601Study Coordinator · Study contact · 551-996-5900More trials in Hackensack
NM
- University of New Mexico Comprehensive Cancer Center ( Site 0022) · Albuquerque, NM 87131Study Coordinator · Study contact · 505-272-4946More trials in Albuquerque
NV
- Comprehensive Cancer Centers of Nevada ( Site 0082) · Las Vegas, NV 89148Study Coordinator · Study contact · 702-952-1251More trials in Las Vegas
NY
- Icahn School of Medicine at Mount Sinai ( Site 0009) · New York, NY 10029Study Coordinator · Study contact · 212-241-6756More trials in New York
- Great Lakes Cancer Care ( Site 0047) · Williamsville, NY 14221Study Coordinator · Study contact · 716-884-3000More trials in Williamsville
OH
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0061) · Columbus, OH 43221Study Coordinator · Study contact · 619-228-4010More trials in Columbus
OR
- VA Portland Health Care System ( Site 0038) · Portland, OR 97239Study Coordinator · Study contact · 503-220-8262More trials in Portland
PA
- Perelman Center for Advanced Medicine ( Site 0067) · Philadelphia, PA 19104Study Coordinator · Study contact · 215-360-0737More trials in Philadelphia
- Abramson Cancer Center - Penn Medicine ( Site 0079) · Philadelphia, PA 19106Study Coordinator · Study contact · 215-829-6088More trials in Philadelphia
TN
- Memphis VA Medical Center ( Site 0072) · Memphis, TN 38105Study Coordinator · Study contact · 901-523-8990More trials in Memphis
- SCRI Oncology Partners ( Site 0074) · Nashville, TN 37203Study Coordinator · Study contact · 615-329-7640More trials in Nashville
- Henry-Joyce Cancer Clinic ( Site 0042) · Nashville, TN 37232Study Coordinator · Study contact · 615-936-8422More trials in Nashville
TX
- Parkland Health & Hospital System ( Site 0069) · Dallas, TX 75235Study Coordinator · Study contact · 214-645-4673More trials in Dallas
- UT Southwestern Medical Center ( Site 0039) · Dallas, TX 75390Study Coordinator · Study contact · 972-332-4682More trials in Dallas
- University of Texas-MD Anderson Cancer Center ( Site 0055) · Houston, TX 77030Study Coordinator · Study contact · 877-632-6789More trials in Houston
VA
- Blue Ridge Cancer Care ( Site 0024) · Roanoke, VA 24014More trials in Roanoke
WA
- VA Puget Sound Health Care System ( Site 0054) · Seattle, WA 98108Study Coordinator · Study contact · 206-762-1010More trials in Seattle
- Fred Hutchinson Cancer Center ( Site 0060) · Seattle, WA 98109Study Coordinator · Study contact · 206-606-7307More trials in Seattle
WI
- University Hospital and UW Health Clinics ( Site 0065) · Madison, WI 53792Study Coordinator · Study contact · 608-915-0100More trials in Madison
- Medical College of Wisconsin ( Site 0008) · Milwaukee, WI 53226Study Coordinator · Study contact · 414-805-0509More trials in Milwaukee