A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)

What this study is about

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about: * The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 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

🚫 You may not be able to join if…

• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis or suspected ILD/pneumonitis
• 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 this trial is running

• UCLA Hematology & Oncology ( Site 0003), Los Angeles, California, United States
• University of California-Irvine Medical Center ( Site 0016), Orange, California, United States
• UCSF Medical Center at Mission Bay ( Site 0034), San Francisco, California, United States
• MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026), Washington D.C., District of Columbia, United States
• University of Michigan ( Site 0021), Ann Arbor, Michigan, United States
• Memorial Sloan Kettering Cancer Center ( Site 0006), New York, New York, United States
• UPMC Hillman Cancer Center ( Site 0014), Pittsburgh, Pennsylvania, United States
• The West Clinic, PLLC dba West Cancer Center ( Site 0005), Germantown, Tennessee, United States
• Fred Hutchinson Cancer Center ( Site 0013), Seattle, Washington, United States
• Instituto Alexander Fleming ( Site 0202), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
• Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200), La Rioja, Argentina
• Macquarie University-MQ Health Clinical Trials Unit ( Site 0801), Macquarie University, New South Wales, Australia

+ 70 more sites.

Who to contact

Toll Free Number · 1-888-577-8839 · Trialsites@msd.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06863272.