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

Description

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).

Conditions

Prostatic Neoplasms

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Study Overview

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Study Details

Study overview

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).

A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

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

Condition
Prostatic Neoplasms
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center Herbert Irving Pavilion, New York, New York, United States, 10032

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Seattle

University of Washington, Seattle, Washington, United States, 98195-9472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Confirmed adenocarcinoma of the prostate which has spread to other body parts
  • * Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
  • * Measurable or evaluable disease
  • * Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug
  • * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • * 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
  • * Active central nervous system (CNS) involvement
  • * Toxicity related to prior anticancer therapy has not adequately recovered
  • * Prior treatment with human kallikrein (KLK) 2-targeted therapy
  • * Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug
  • * Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug
  • * Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug
  • * Solid organ or bone marrow transplantation
  • * Major clotting diseases within one month prior to the first dose of study drug
  • * Active autoimmune disease within 12 months prior to the first dose of study drug
  • * Active infection
  • * Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug
  • * Clinically significant lung diseases
  • * Active or chronic hepatitis B or hepatitis C infection
  • * Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)
  • * Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2026-02-16