Prostate Cancer Clinical Trial

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

Summary

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).

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Full Description

JNJ-78278343 is a humanized immunoglobulin (Ig)G1-based bispecific antibody designed to direct T lymphocytes (T cells) to human kallikrein 2 (hK2or KLK2) positive target tumor cells. One arm of JNJ-78278343 binds to the cluster of differentiation (CD)3 receptor complex present on T cells and the other arm binds to KLK2 present on target tumor cells leading to the activation of the T cells and T-cell-mediated lysis of the KLK2 bearing tumor cells. JNJ-78278343 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). KLK2 expression is highly restricted in normal tissues and highly enriched in prostate adenocarcinoma and its expression is mostly maintained throughout disease progression, making KLK2 an attractive target for therapy. This study will be conducted in 2 phases: a Screening Phase (up to 30 days), a Treatment Phase (start of study drug administration) with an end of treatment (EOT) visit (up to 30 plus 14 days after last dose of study drug or prior to the start of a new anticancer therapy), whichever comes first). The total duration of the study is up to 1 year and 10 months. Safety assessment will include adverse events (AEs) including dose-limiting toxicity (DLT), serious adverse events (SAEs), physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, Eastern Cooperative Oncology Group (ECOG) performance status, and neurologic examination.

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Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Disease conditions

Active central nervous system (CNS) involvement
Toxicity related to prior anticancer therapy has not adequately recovered

Prior/Concomitant Therapy

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

Prior/Concurrent Medical Conditions

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

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04898634

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 11 Locations for this study

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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, United States
Centre Leon Bérard
Lyon Cedex 8 , 69373, France
APHM Hopital Timone
Marseille , 13005, France
Institut Gustave Roussy
Villejuif , 94800, France
NKI-AVL, Amsterdam
Amsterdam , 1066 , Netherlands
Erasmus MC
Rotterdam , 3015 , Netherlands
Hosp. Univ. Fund. Jimenez Diaz
Madrid , 28040, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Virgen de La Victoria
Málaga , 29010, Spain

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04898634

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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