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New treatment for metastatic prostate cancer using ifinatamab deruxtecan

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

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06925737

This study is testing a new treatment called ifinatamab deruxtecan to see if it helps men with advanced prostate cancer live longer and feel better compared to standard chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1440 (estimated)
Ages18 Years and up
SexMale
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionstrastuzumab, chemotherapy, radiation, ifinatamab
Locations282 sites (Phoenix, Arizona and 281 other locations)
Trial IDNCT06925737 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the effectiveness of ifinatamab deruxtecan (I-DXd) in treating patients with metastatic castration-resistant prostate cancer (mCRPC). Participants will receive I-DXd and their outcomes will be compared to those receiving standard chemotherapy. The primary goal is to determine if I-DXd can improve overall survival and delay cancer progression compared to traditional treatments. The study aims to provide insights into a novel therapeutic approach for a challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates are men diagnosed with metastatic castration-resistant prostate cancer who have progressed on androgen deprivation therapy and have received prior treatment with androgen receptor pathway inhibitors.

Not a fit: Patients with a history of interstitial lung disease or significant cardiovascular issues, as well as those who have previously received taxane-based chemotherapy for mCRPC, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced prostate cancer.

How similar studies have performed: Other studies have shown promise with similar targeted therapies in prostate cancer, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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:

  1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
  2. Has current ILD/pneumonitis
  3. 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

Where this trial is running

Phoenix, Arizona and 281 other locations

+232 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Prostate CancerProstatic Neoplasms
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.