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

NCT ID: NCT04898634

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2027-02-10

Brief 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

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ-78278343

Participants will receive JNJ-78278343. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 at recommended phase 2 dose (RP2D) as determined in Part 1. Participants who are still on study treatment (i.e., who are in Treatment Phase) at the time of the long term extension (LTE) will continue to receive study treatment until they reach a reason for discontinuation of treatment or until further notification by the sponsor of a different means for continued supply of study treatment, whichever occurs first.

Group Type: EXPERIMENTAL

JNJ-78278343

Intervention Type: DRUG

JNJ-78278343 will be administered.

Interventions

JNJ-78278343

JNJ-78278343 will be administered.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Columbia University Medical Center Herbert Irving Pavilion

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Washington

Seattle, Washington, United States

Peking University Third Hospital

Beijing, , China

Chongqing University Cancer Hospital

Chongqing, , China

Sun Yat Sen University Cancer Center

Guangzhou, , China

First Affiliated Hospital Of Wenzhou Medical College

Wenzhou, , China

Centre Leon Berard

Lyon, , France

APHM Hopital Timone

Marseille, , France

Institut Gustave Roussy

Villejuif, , France

National Cancer Center Hospital East

Kashiwa, , Japan

Yokohama City University Medical Center

Yokohama, , Japan

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

Hosp Univ Fund Jimenez Diaz

Madrid, , Spain

Hosp Univ Hm Sanchinarro

Madrid, , Spain

Hosp Virgen de La Victoria

Málaga, , Spain

Countries

United States; China; France; Japan; Netherlands; Spain

References

Stein MN, Vinceneux A, Robbrecht D, Doger B, Autio KA, Schweizer MT, Calvo E, Medina L, Van Dongen M, Deville JL, Bernard-Tessier A, Ghosh D, Shotts K, Shen F, Jaiprasart P, Chaudhary R, Wu S, Cartee L, Schnepp R, Gaut D, Lauring J, Wang SC, Villalobos VM, Baldini C. Pasritamig, a First-in-Class, Bispecific T-Cell Engager Targeting Human Kallikrein 2, in Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. J Clin Oncol. 2025 Aug;43(22):2515-2526. doi: 10.1200/JCO-25-00678. Epub 2025 Jun 1.

Reference Type: DERIVED

PMID: 40450573 (View on PubMed)

Other Identifiers

78278343PCR1001

Identifier Type: OTHER

Identifier Source: secondary_id

2020-005970-83

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-506585-31-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108958

Identifier Type: -

Identifier Source: org_study_id