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A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Enrolling
Phase 3

Conditions

Prostatic Neoplasms
Prostate Cancer

Treatments

Drug: Ifinatamab deruxtecan
Drug: Prednisone
Drug: Docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT06925737
2400-001
2024-517423-40-00 (Registry Identifier)
U1111-1312-2498 (Registry Identifier)

Details and patient eligibility

About

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,

Enrollment

1,440 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

  • 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 exclusion criteria include but are not limited to the following:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,440 participants in 2 patient groups

I-DXd
Experimental group
Description:
Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
Treatment:
Drug: Ifinatamab deruxtecan
Docetaxel
Active Comparator group
Description:
Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label
Treatment:
Drug: Docetaxel
Drug: Prednisone

Trial contacts and locations

9

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Central trial contact

Toll Free Number

Data sourced from clinicaltrials.gov

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