New treatment for metastatic prostate cancer using ifinatamab deruxtecan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Arizona - Phoenix ( Site 0044)
  Phoenix, Arizona, United States Recruiting
• Community Cancer Institute ( Site 0081)
  Clovis, California, United States Recruiting
• City of Hope Comprehensive Cancer Center ( Site 0049)
  Duarte, California, United States Recruiting
• City of Hope Lennar Foundation Cancer Center ( Site 0059)
  Irvine, California, United States Recruiting
• Moores Cancer Center ( Site 0010)
  La Jolla, California, United States Recruiting
• Veterans Affairs Long Beach Healthcare System ( Site 0058)
  Long Beach, California, United States Recruiting

+253 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.