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MK-2400-01A Substudy: A Phase I/II, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-Based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)

UCI Specialty Area: Cancer
Principal Investigator: Nataliya Mar
A Study On:
Prostate

Study Description

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.

Eligibility

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 received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment

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)
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Eric Vilain, MD, PhD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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    Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information
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