A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
Who is this study for? Adult male patients with Prostate Cancer
What treatments are being studied? JNJ-78278343
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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).
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
Columbia University Medical Center Herbert Irving Pavilion
ACTIVE_NOT_RECRUITING
New York
Memorial Sloan Kettering Cancer Center
ACTIVE_NOT_RECRUITING
New York
Washington
University of Washington
ACTIVE_NOT_RECRUITING
Seattle
Other Locations
China
Peking University Third Hospital
ACTIVE_NOT_RECRUITING
Beijing
Chongqing University Cancer Hospital
ACTIVE_NOT_RECRUITING
Chongqing
Sun Yat Sen University Cancer Center
ACTIVE_NOT_RECRUITING
Guangzhou
First Affiliated Hospital Of Wenzhou Medical College
ACTIVE_NOT_RECRUITING
Wenzhou
France
Centre Leon Berard
RECRUITING
Lyon
APHM Hopital Timone
COMPLETED
Marseille
Institut Gustave Roussy
RECRUITING
Villejuif
Japan
National Cancer Center Hospital East
ACTIVE_NOT_RECRUITING
Kashiwa
Yokohama City University Medical Center
ACTIVE_NOT_RECRUITING
Yokohama
Netherlands
Antoni van Leeuwenhoek
COMPLETED
Amsterdam
Erasmus MC
COMPLETED
Rotterdam
Spain
Hosp Univ Fund Jimenez Diaz
RECRUITING
Madrid
Hosp Univ Hm Sanchinarro
COMPLETED
Madrid
Hosp Virgen de La Victoria
RECRUITING
Málaga
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date:2021-07-13
Estimated Completion Date:2027-02-10
Participants
Target number of participants:216
Treatments
Experimental: 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.