A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

  • Recruiting
  • Treatment
  • Interventional
  • Drug
  • PHASE1
  • Janssen Research & Development, LLC
  • 18 Years -


Study Purpose

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

Intervention

Drug : JNJ-78278343


Eligibility Requirements

info icon Confirmed adenocarcinoma of the prostate which has spread to other body parts

info icon Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy

info icon Measurable or evaluable disease

info icon Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug

info icon Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

info icon Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog

info icon Minimum age: 18

info icon Disease conditions

info icon Active central nervous system (CNS) involvement

info icon Toxicity related to prior anticancer therapy has not adequately recovered

info icon Prior/Concomitant Therapy

info icon Prior treatment with human kallikrein (KLK) 2-targeted therapy

info icon Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug

info icon Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug

info icon Prior/Concurrent Medical Conditions

info icon Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug

info icon Solid organ or bone marrow transplantation

info icon Major clotting diseases within one month prior to the first dose of study drug

info icon Active autoimmune disease within 12 months prior to the first dose of study drug

info icon Active infection

info icon Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug

info icon Clinically significant lung diseases

info icon Active or chronic hepatitis B or hepatitis C infection

info icon Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)

info icon Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment

Recruiting status

Recruiting

Estimated enrollment

260

 
Study start date

Jul 13, 2021

Study end date

Feb 16, 2026

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1

Allocation

Na

 

Sponsor:

Janssen Research & Development, LLC

Collaborator:

N/A

Investigator:

Janssen Research & Development, LLC Clinical Trial

NCT04898634

Clinic Location Investigator Distance RECRUITING STATUS Contact