A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)
Fase: Phase I-II clinical trials
Principal Investigator: Dott.ssa Verzoni Elena
Struttura Principale: Oncologia Medica Genitourinaria
Farmaco: Ifinatamab Deruxtecan
Patologie: Tumori della prostata
Each participant will participate in the study for approximately 2 years from the time the participant provides documented informed consent through the final protocol-specified contact. After a screening period of up to 42 days, each participant will be receiving assigned study intervention until radiographically documented disease progression by local assessment per PCWG Modified RECIST 1.1, unacceptable AEs, illness preventing further treatment, investigator’s decision to discontinue the participant, withdrawal of consent, or administrative reasons requiring treatment discontinuation. After the end of treatment each participant will be followed for the occurrence of adverse events. After screening, each participant will be assigned to receive study intervention until one of the conditions for discontinuation of study intervention is met. Participants assigned to receive docetaxel will receive study intervention for up to 10 cycles. Participants who discontinue for reasons other than radiographic disease progression will have posttreatment follow-up imaging for disease status until any of the conditions for discontinuation of imaging are met. After the end of treatment, each participant will be followed for the occurrence of AEs, SAEs, and other reportable safety events. All participants will be followed for overall survival until death, withdrawal of consent, the end of the study, or enrollment into an extension study
Last update: 17/04/2026