A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04898634|
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : June 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: JNJ-78278343||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer|
|Actual Study Start Date :||July 13, 2021|
|Estimated Primary Completion Date :||May 20, 2023|
|Estimated Study Completion Date :||December 30, 2023|
Participants will receive JNJ-78278343 subcutaneously (SC). 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 SC at recommended phase 2 dose (RP2D) as determined in Part 1.
JNJ-78278343 will be administered subcutaneously.
- Part 1 and 2: Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 1 year and 10 months ]An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
- Part 1 and 2: Number of Participants With AEs by Severity [ Time Frame: Up to 1 year and 10 months ]Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
- Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 1 year and 10 months ]Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
- Serum Concentration of JNJ-78278343 [ Time Frame: Up to 1 year and 10 months ]Serum concentrations of JNJ-78278343 will be determined.
- Systemic Cytokine Concentrations [ Time Frame: Up to 1 year and 10 months ]Cytokine concentrations will be determined for biomarker assessment.
- Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Up to 1 year and 10 months ]Serum PSA concentration will be measured.
- Number of Participants With Anti-JNJ-78278343 Antibodies [ Time Frame: Up to 1 year and 10 months ]Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.
- Objective Response Rate (ORR) [ Time Frame: Up to 1 year and 10 months ]ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).
- PSA Response Rate [ Time Frame: Up to 1 year and 10 months ]PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment.
- Duration of Response (DOR) [ Time Frame: Up to 1 year and 10 months ]DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898634
|Contact: Study Contact||844-434-4210||Participate-In-This-Study@its.jnj.com|
|United States, New York|
|Columbia University Medical Center, Herbert Irving Pavilion||Recruiting|
|New York, New York, United States, 10032|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|United States, Washington|
|University of Washington||Not yet recruiting|
|Seattle, Washington, United States, 98195-9472|
|Centre Leon Bérard||Recruiting|
|Lyon Cedex 8, France, 69373|
|APHM Hopital Timone||Recruiting|
|Marseille, France, 13005|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94800|
|Amsterdam, Netherlands, 1066 CX|
|Rotterdam, Netherlands, 3015 GD|
|Hosp. Univ. Fund. Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|Hosp. Univ. Hm Sanchinarro||Recruiting|
|Madrid, Spain, 28050|
|Hosp. Virgen de La Victoria||Recruiting|
|Málaga, Spain, 29010|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|