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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
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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).

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: JNJ-78278343 Phase 1

Detailed Description:
JNJ-78278343 is a humanized immunoglobulin (Ig)G1-based bispecific antibody designed to direct T lymphocytes (T cells) to human kallikrein 2 (hK2or KLK2) positive target tumor cells. One arm of JNJ-78278343 binds to the cluster of differentiation (CD)3 receptor complex present on T cells and the other arm binds to KLK2 present on target tumor cells leading to the activation of the T cells and T-cell-mediated lysis of the KLK2 bearing tumor cells. JNJ-78278343 is being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). KLK2 expression is highly restricted in normal tissues and highly enriched in prostate adenocarcinoma and its expression is mostly maintained throughout disease progression, making KLK2 an attractive target for therapy. This study will be conducted in 2 phases: a Screening Phase (up to 30 days), a Treatment Phase (start of study drug administration) with an end of treatment (EOT) visit (up to 30 plus 14 days after last dose of study drug or prior to the start of a new anticancer therapy), whichever comes first). The total duration of the study is up to 1 year and 10 months. Safety assessment will include adverse events (AEs) including dose-limiting toxicity (DLT), serious adverse events (SAEs), physical examination, vital signs, electrocardiogram, clinical safety laboratory assessments, Eastern Cooperative Oncology Group (ECOG) performance status, and neurologic examination.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: JNJ-78278343
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.
Drug: JNJ-78278343
JNJ-78278343 will be administered subcutaneously.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Serum Concentration of JNJ-78278343 [ Time Frame: Up to 1 year and 10 months ]
    Serum concentrations of JNJ-78278343 will be determined.

  2. Systemic Cytokine Concentrations [ Time Frame: Up to 1 year and 10 months ]
    Cytokine concentrations will be determined for biomarker assessment.

  3. Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Up to 1 year and 10 months ]
    Serum PSA concentration will be measured.

  4. 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.

  5. 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).

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed adenocarcinoma of the prostate which has spread to other body parts
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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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
France
Centre Leon Bérard Recruiting
Lyon Cedex 8, France, 69373
APHM Hopital Timone Recruiting
Marseille, France, 13005
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Netherlands
NKI-AVL, Amsterdam Recruiting
Amsterdam, Netherlands, 1066 CX
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD
Spain
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
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04898634    
Other Study ID Numbers: CR108958
2020-005970-83 ( EudraCT Number )
78278343PCR1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: June 21, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Janssen Research & Development, LLC:
Metastatic castration-resistant prostate cancer (mCRPC)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases