drugset / Trial / NCT06863272
A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: * The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.
Timeline
- Start
- 2025-07-03
- Primary completion
- 2031-10-01
- Completion
- 2031-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | — | Oral |
| Comparator | Docetaxel | Small molecule | — | Intravenous |
| Subject | Enzalutamide | Other / unclassified | — | Oral |
| Subject | Ifinatamab Deruxtecan | Other / unclassified | — | Intravenous |
| Subject | Opevesostat | Small molecule | — | Oral |