Actively Recruiting
A Phase 3 Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Men With Metastatic Castration-Resistant Prostate Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
1440
Participants Needed
285
Research Sites
132 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new medicine called ifinatamab deruxtecan I-DXd for treating men with metastatic castration-resistant prostate cancer mCRPC. The study aims to find out if people receiving I-DXd live longer overall and have longer periods without cancer growth or spread compared to those receiving chemotherapy. This is a Phase 3, open-label trial sponsored by Merck Sharp Dohme LLC. Participants in the study will be randomly assigned to receive either I-DXd at a dose of 12 mgkg every 3 weeks or a combination of docetaxel chemotherapy 75 mgm every 3 weeks with daily prednisone. I-DXd is given by intravenous infusion every 3 weeks until the disease progresses or side effects prevent continued treatment. Premedication is given before I-DXd to help prevent nausea and vomiting. During the study, participants will be closely monitored for overall survival and radiographic progression-free survival for up to about 36 months. Researchers will also assess several other outcomes including response rates, time to progression, pain progression, prostate-specific antigen changes, and side effects. Safety and treatment tolerability will be tracked throughout, and participants health will be regularly evaluated with scans and other tests.
CONDITIONS
Brief Title
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male adults aged 18 years or older
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Prostate cancer progression while on androgen deprivation therapy or after bilateral orchiectomy within 6 months prior to screening
- Evidence of distant metastatic disease documented by bone scan or CT/MRI
- Prior treatment with 1 or 2 androgen receptor pathway inhibitors with progression during or after at least 8 weeks of treatment
- Provided tumor tissue from a recent biopsy after progression on prior therapy
- Recovered from adverse events related to previous anticancer treatments
You will not qualify if you...
- Unable to swallow tablets or capsules
- History of interstitial lung disease (ILD) or pneumonitis requiring steroids, except radiation pneumonitis without steroid use
- Current ILD or pneumonitis
- Suspected ILD that cannot be ruled out
- Severe pulmonary compromise from other lung illnesses
- Uncontrolled or significant cardiovascular disease
- Prior taxane-based chemotherapy for metastatic castration-resistant prostate cancer
- Prior discontinuation of antibody drug conjugate containing exatecan derivative due to toxicity
- Presence of "superscan" on bone scan
Research Team
T
Toll Free Number
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here