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)

Launched by MERCK SHARP & DOHME LLC · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC), which means their cancer has spread and is no longer responding to hormone therapy. The trial aims to find out how safe the treatment is, how well patients tolerate it, and what the right dose is when given alone or in combination with other therapies. Researchers will also monitor levels of a specific protein called prostate-specific antigen (PSA) in the blood, which can help indicate how the cancer is responding to treatment.

To participate in this trial, individuals must have a confirmed diagnosis of prostate cancer that has spread, and they should have previously received certain hormone therapies that didn’t work. Additionally, eligible participants should be generally healthy, with a good performance status, meaning they can carry out their daily activities. The trial is not yet recruiting, but if you or a loved one are interested, you can expect regular check-ups and monitoring throughout the study to ensure safety and track the treatment’s effectiveness.

Gender

ALL

Eligibility 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 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
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• • 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