A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Status
RECRUITING
Phase
PHASE3
Age
≥ 18 Years
Enrollments
1440Conditions
Prostate Cancer, Prostatic NeoplasmsDrugs
Ifinatamab deruxtecan, Docetaxel, PrednisoneSummary
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,
Locations
34 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Study Coordinator
- 855-776-0015
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 626-256-4673
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 626-256-4673
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 858-822-6100
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 310-423-7600
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 203-737-6087
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 202-745-8000
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 855-776-0015
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 404-727-6123
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 404-778-4824
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 312-355-1625
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 866-340-4488
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 617-667-2100
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 617-632-6049
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 734-647-8902
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 313-725-7920
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 616-399-6500
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 855-776-0015
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 612-341-4800
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 612-341-4800
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 406-238-6290
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 402-334-4773
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 402-334-4773
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 551-996-5900
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 212-241-6756
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 716-884-3000
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 215-360-0737
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 215-829-6088
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 901-523-8990
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 615-329-7640
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 972-332-4682
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 877-632-6789
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 540-982-0237
Study Director
- Medical Director
Status
- RECRUITING
Contact Person
- Study Coordinator
- 206-762-1010
Study Director
- Medical Director
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
Outcome Measures
Primary Outcome Measures
Overall Survival (OS)
Radiographic Progression Free Survival (rPFS)
Secondary Outcome Measures
Time to First Subsequent Therapy (TFST)
Objective Response (OR)
Duration of Response (DOR)
Time to Pain Progression (TTPP)
Time to Prostate-specific Antigen (PSA) Progression
PSA Response
Time to First Symptomatic Skeletal-related Event (SSRE)
Number of Participants Who Experienced at least One Adverse Event (AE)
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timeline
Last Updated
December 11, 2025Start Date
April 13, 2025Today
March 31, 2026Completion Date ( Estimated )
January 6, 2031
Sponsors of this trial
Lead Sponsor
Merck Sharp & Dohme LLCCollaborating Sponsors
Daiichi Sankyo
RECRUITING 
18 - 80 Years