Clinical trial NCT04898634: A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
Official title: A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostatic Neoplasms
Keywords: Metastatic castration-resistant prostate cancer (mCRPC)
Advanced prostate cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-05-24
Enrollment: 260
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Part 1 and 2: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 1 year and 10 months
measure: Part 1 and 2: Number of Participants With AEs by Severity
timeFrame: Up to 1 year and 10 months
measure: Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
timeFrame: Up to 1 year and 10 months
Secondary outcomes:
measure: Serum Concentration of JNJ-78278343
timeFrame: Up to 1 year and 10 months
measure: Systemic Cytokine Concentrations
timeFrame: Up to 1 year and 10 months
measure: Serum Prostate Specific Antigen (PSA) Concentration
timeFrame: Up to 1 year and 10 months
measure: Number of Participants With Anti-JNJ-78278343 Antibodies
timeFrame: Up to 1 year and 10 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 1 year and 10 months
measure: Radiographic Progression-free Survival (rPFS)
timeFrame: Up to 1 year and 10 months
measure: PSA Response Rate
timeFrame: Up to 1 year and 10 months
measure: Duration of Response (DOR)
timeFrame: Up to 1 year and 10 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center Herbert Irving Pavilion
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
city: Guang Zhou Shi
country: China
facility: Sun Yat Sen University Cancer Center
city: Wen Zhou Shi
country: China
facility: First Affiliated Hospital Of Wenzhou Medical College
city: Lyon Cedex 8
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: APHM Hopital Timone
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Madrid
country: Spain
facility: Hosp Univ Fund Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp Univ Hm Sanchinarro
city: Málaga
country: Spain
facility: Hosp Virgen de La Victoria
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: