Trial Details
A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)
NCT06925737
RECRUITING
DESCRIPTION
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,
CONDITIONS
Prostate Cancer Prostatic Neoplasms
ELIGIBILITY CRITERIA
- Inclusion Criteria
- :
The main
- 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
- 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
