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

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

Last Updated February 20, 2025

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CR108958

OVERVIEW

Sexes Eligible for Study
male
Age
18+ years
Phase
phase 1

1
Sites
11 Sites
Status

Recruiting

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).

CONDITIONS

Prostate Cancer

ELIGIBILITY

Inclusion 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

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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, France, Netherlands, Spain

Country (4)	City or Province (11)	Status
United States	New York Columbia University Medical Center Herbert Irving Pavilion	RECRUITING
United States	New York Memorial Sloan Kettering Cancer Center	RECRUITING
United States	Seattle University of Washington	RECRUITING
France	Lyon Cedex 8 Centre Leon Berard	RECRUITING
France	Marseille APHM Hopital Timone	RECRUITING
France	Villejuif Institut Gustave Roussy	RECRUITING
Netherlands	Rotterdam Erasmus MC	RECRUITING
Spain	Madrid Hosp Univ Fund Jimenez Diaz	RECRUITING
Spain	Málaga Hosp Virgen de La Victoria	RECRUITING
Netherlands	Amsterdam NKI AVL Amsterdam	COMPLETED
Spain	Madrid Hosp Univ Hm Sanchinarro	RECRUITING

Geo Locations

40.71427, -74.00597

47.60621, -122.33207

45.74848, 4.84669

43.29551, 5.38958

48.7939, 2.35992

51.9225, 4.47917

40.4165, -3.70256

36.72016, -4.42034

52.37403, 4.88969

40.4165, -3.70256

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Corresponds to individual site.

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