Clinical Trial 23644

• Overview

  Study Title:

  A Phase 3 Randomized, Double-blind, Placebo-controlled Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, + Best Supportive Care Versus Best Supportive Care for Metastatic Castration-resistant Prostate Cancer

  Summary:

  The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in combination with best supportive care (BSC) as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

  Objective:

  Primary Objectives - To determine if pasritamig + BSC compared to placebo + BSC is superior in OS. Key Secondary -To compare the clinical benefit of pasritamig + BSC to placebo + BSC. Other Secondary -To compare the clinical benefit of pasritamig + BSC to placebo + BSC. -To compare the safety profile of pasritamig + BSC to placebo + BSC.

• Treatments

  Therapies:

  Bispecific Antibody

  Medications:

  Pasritamig (); Placebo ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Histologically confirmed adenocarcinoma of the prostate
  • Metastatic castration-resistant prostate cancer (mCRPC): Disease that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs at the time of screening
  • PSA greater than or equal to (>=) 2 nanogram per milliliter (ng/mL) at screening
  • In the opinion of the investigator, the next best treatment option is a clinical trial
  • Participants should have had all life-prolonging therapies for which they are clinically eligible in the opinion of the investigator and to which they have access. Prior therapies could have been given in any disease setting (not limited to mCRPC)
  • Prior orchiectomy or medical castration (receiving ongoing ADT with a GnRH analog [agonist or antagonist]) prior to the first dose of study treatment and must continue this therapy throughout the treatment phase
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Additional criteria will apply

• Exclusion Criteria

  Key Exclusion Criteria:
  • Venous thromboembolic events within 1 month prior to the first dose of study treatment; uncomplicated (Grade > Active autoimmune disease within the past 12 months that requires systemic immunosuppressive medications (eg, chronic corticosteroid, methotrexate, or tacrolimus)
  • Clinically significant pulmonary compromise, particularly a requirement for supplemental oxygen use (>2 liters per minute (L/min) by nasal cannula) to maintain adequate oxygenation
  • Prior or concurrent second malignancy (other than the disease under study) for which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)
  • Additional criteria will apply.

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