Ifinatamab deruxtecan alone or with other drugs for metastatic castration‑resistant prostate cancer

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 phase 1/2 study gives ifinatamab deruxtecan (I-DXd) alone or combined with agents such as docetaxel, abiraterone, enzalutamide, or MK-5684 to men with metastatic castration‑resistant prostate cancer. Phase 1 focuses on finding safe dose levels and tolerability for combination regimens, while phase 2 looks for signals of efficacy, including changes in PSA and disease control. Participants must meet criteria such as prior androgen-deprivation therapy, progression after 1–2 androgen receptor pathway inhibitors, and ECOG performance status 0–1. Safety, side effects, and anti-tumor activity are closely monitored at participating US academic centers under a master screening protocol.

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 before Screening
* Has current evidence of distant metastatic disease
* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment
* Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization
* Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator

Exclusion Criteria:

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

* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current ILD, clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Uncontrolled or significant cardiovascular disease
* History of pituitary dysfunction
* Poorly controlled diabetes mellitus
* History or current condition of adrenal insufficiency (eg, Addison's disease)
* Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC).
* Chronic steroid treatment (dose of \>10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of allogeneic tissue/solid organ transplant

Where it's running

• UCLA Hematology & Oncology ( Site 0003)
  Los Angeles, California, United States Recruiting
• University of California-Irvine Medical Center ( Site 0016)
  Orange, California, United States Recruiting
• UCSF Medical Center at Mission Bay ( Site 0034)
  San Francisco, California, United States Recruiting
• MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
  Washington D.C., District of Columbia, United States Recruiting
• University of Michigan ( Site 0021)
  Ann Arbor, Michigan, United States Recruiting
• Memorial Sloan Kettering Cancer Center ( Site 0006)
  New York, New York, United States Recruiting

+32 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.