ACTIVE_NOT_RECRUITING

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

Conditions

Prostatic Neoplasms Metastatic castration-resistant prostate cancer (mCRPC)Advanced prostate cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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).

Official Title

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

Quick Facts

Study Start:2021-07-13

Study Completion:2027-02-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04898634

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

STUDY_DIRECTOR

Janssen Research & Development, LLC

Study Locations (Sites)

Columbia University Medical Center Herbert Irving Pavilion

New York, New York, 10032

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

University of Washington

Seattle, Washington, 98195-9472

United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-13

Study Completion Date2027-02-10

Study Record Updates

Study Start Date2021-07-13

Study Completion Date2027-02-10

Terms related to this study

Keywords Provided by Researchers

Metastatic castration-resistant prostate cancer (mCRPC)
Advanced prostate cancer

Additional Relevant MeSH Terms

Prostatic Neoplasms