Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06925737

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136), Berazategui, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
  • Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
  • Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
  • Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
  • Has recovered from adverse events (AEs) due to previous anticancer therapies

Exclusion criteria

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

  • Is unable to swallow tablets/capsules
  • Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
  • Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
  • Has current ILD/pneumonitis
  • Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Has uncontrolled or significant cardiovascular disease
  • Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)
  • Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities
  • Has a "superscan" bone scan

Treatment and study plan

Ifinatamab Deruxtecan

Drug

Administered via intravenous (IV) infusion every 3 weeks (q3w) until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Other names: I-DXd, MK-2400, DS-7300a

docetaxel

Drug

Administered via IV infusion q3W until disease progression, unacceptable adverse events (AEs), or other cessation of treatment

Prednisone

Drug

Oral tablet administered once per day or per approved product label

Other names: Prednisone acetate, Prednisolone, Prednisolone acetate

Rescue medication

Drug

Before administering each dose of I-DXd, premedication is required for prevention of nausea and vomiting with a 2 or 3 drug combination regimen (eg, corticosteroids with either a 5-HT3 receptor antagonist or an NK-1 receptor antagonist and other drugs as indicated) per approved product label

Other names: 5-HT3 receptor antagonist, NK-1 receptor antagonist, Corticosteroid

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 36 months

    OS is defined as the time from randomization to death due to any cause.

  2. Radiographic Progression Free Survival (rPFS)

    Time frame: Up to approximately 36 months

    rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Time to First Subsequent Therapy (TFST)

    Time frame: Up to approximately 36 months

    TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first.

  2. Objective Response Rate (ORR)

    Time frame: Up to approximately 36 months

    The ORR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG-modified RECIST 1.1 as assessed by BICR.

  3. Duration of Response (DOR)

    Time frame: Up to approximately 36 months

    For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first.

  4. Time to Pain Progression (TTPP)

    Time frame: Up to approximately 36 months

    TTPP is defined as the time from randomization to pain progression based on the brief pain inventory-short form (BPI-SF) Item 3 "worst pain in 24 hours" and opiate analgesic use (AQA score).

  5. Time to Prostate-specific Antigen (PSA) Progression

    Time frame: Up to approximately 36 months

    Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is defined as the first date that 1) ≥25% increase and ≥2 ng/mL above the nadir which is confirmed by a second value≥3 weeks later if there is PSA decline from baseline, 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.

  6. PSA Response Rate

    Time frame: Up to approximately 36 months

    PSA response rate is defined as the proportion of participants in the analysis population who have a PSA reduction of ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG criteria.

  7. Time to First Symptomatic Skeletal-Related Event (SSRE)

    Time frame: Up to approximately 36 months

    Time to first SSRE is defined as the time from randomization to the first occurrence of any of the following symptomatic skeletal-related events:

    • use of EBRT to prevent or relieve skeletal symptoms,
    • new symptomatic pathologic bone fracture (vertebral or non-vertebral),
    • spinal cord compression,
    • a tumor-related orthopedic surgical intervention.

  8. Number of Participants Who Experienced at Least One Adverse Event (AE)

    Time frame: Up to approximately 36 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  9. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

    Time frame: Up to approximately 36 months

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Apr 13, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.