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NCT06863272 | NOT YET RECRUITING | Castration-Resistant Prostatic Cancer

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)
Sponsor:

Merck Sharp & Dohme LLC

Brief Summary:

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.

Condition or disease

Castration-Resistant Prostatic Cancer

Metastasis

Intervention/treatment

Docetaxel

Ifinatamab Deruxtecan

MK-5684

Abiraterone

Enzalutamide

Phase

PHASE1

PHASE2

Detailed Description:

This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC). The master screening protocol is MK-2400-U01.

Study Type : INTERVENTIONAL
Estimated Enrollment : 360 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : MK-2400-01A Substudy: A Phase 1/2, 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)
Actual Study Start Date : 2025-06-17
Estimated Primary Completion Date : 2030-02-18
Estimated Study Completion Date : 2030-02-18

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
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)

Location Details

NCT06863272

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