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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)
Trial Status: active
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.
Inclusion 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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06863272.