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)

MK-2400-01A Substudy: 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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01

Conditions

• Castration-Resistant Prostatic Cancer
• Metastasis

Interventions

Type	Name	Description
DRUG	Docetaxel	Administered via Intravenous (IV) infusion at a specified dose on specified days
DRUG	Ifinatamab Deruxtecan	Administered via IV infusion at a specified dose on specified days
DRUG	MK-5684	Administered orally at a specified dose on specified days
DRUG	Abiraterone	Administered orally at a specified dose on specified days
DRUG	Enzalutamide	Administered orally at a specified dose on specified days
DRUG	Rescue Medication	Before each dose of I-DXd, participants are required to take premedication for prevention of nausea and vomiting with a 2- or 3-drug combination regimen (eg, dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist as well as other drugs as indicated) per approved product label.

Timeline

• Start date: 2025-07-03
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2025-03-07
• Last updated: 2026-04-13

Locations

74 sites across 19 countries: United States, Argentina, Australia, Brazil, Canada, Chile, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study