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

Primary Purpose

Prostatic Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-78278343
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Metastatic castration-resistant prostate cancer (mCRPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Medical Center, Herbert Irving PavilionRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • University of WashingtonRecruiting
  • Centre Leon BérardRecruiting
  • APHM Hopital TimoneRecruiting
  • Institut Gustave RoussyRecruiting
  • NKI-AVL, AmsterdamRecruiting
  • Erasmus MCRecruiting
  • Hosp. Univ. Fund. Jimenez DiazRecruiting
  • Hosp. Univ. Hm SanchinarroRecruiting
  • Hosp. Virgen de La VictoriaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JNJ-78278343

Arm Description

Participants will receive JNJ-78278343 either subcutaneously (SC injection or SC infusion) or intravenous (IV) infusion. 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 either SC or IV at recommended phase 2 dose (RP2D) as determined in Part 1.

Outcomes

Primary Outcome Measures

Part 1 and 2: Number of Participants With Adverse Events (AEs)
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
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) and immune effector cell associated neurotoxicity syndrome (ICANS) 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)
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

Serum Concentration of JNJ-78278343
Serum concentrations of JNJ-78278343 will be determined.
Systemic Cytokine Concentrations
Cytokine concentrations will be determined for biomarker assessment.
Serum Prostate Specific Antigen (PSA) Concentration
Serum PSA concentration will be measured.
Number of Participants With Anti-JNJ-78278343 Antibodies
Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.
Objective Response Rate (ORR)
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
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)
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.

Full Information

First Posted
May 20, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04898634
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Metastatic castration-resistant prostate cancer (mCRPC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JNJ-78278343
Arm Type
Experimental
Arm Description
Participants will receive JNJ-78278343 either subcutaneously (SC injection or SC infusion) or intravenous (IV) infusion. 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 either SC or IV at recommended phase 2 dose (RP2D) as determined in Part 1.
Intervention Type
Drug
Intervention Name(s)
JNJ-78278343
Intervention Description
JNJ-78278343 will be administered subcutaneously (injection or infusion) or via intravenous infusion.
Primary Outcome Measure Information:
Title
Part 1 and 2: Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Part 1 and 2: Number of Participants With AEs by Severity
Description
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) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Time Frame
Up to 1 year and 10 months
Title
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Description
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.
Time Frame
Up to 1 year and 10 months
Secondary Outcome Measure Information:
Title
Serum Concentration of JNJ-78278343
Description
Serum concentrations of JNJ-78278343 will be determined.
Time Frame
Up to 1 year and 10 months
Title
Systemic Cytokine Concentrations
Description
Cytokine concentrations will be determined for biomarker assessment.
Time Frame
Up to 1 year and 10 months
Title
Serum Prostate Specific Antigen (PSA) Concentration
Description
Serum PSA concentration will be measured.
Time Frame
Up to 1 year and 10 months
Title
Number of Participants With Anti-JNJ-78278343 Antibodies
Description
Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.
Time Frame
Up to 1 year and 10 months
Title
Objective Response Rate (ORR)
Description
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).
Time Frame
Up to 1 year and 10 months
Title
PSA Response Rate
Description
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.
Time Frame
Up to 1 year and 10 months
Title
Duration of Response (DOR)
Description
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.
Time Frame
Up to 1 year and 10 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Columbia University Medical Center, Herbert Irving Pavilion
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-9472
Country
United States
Individual Site Status
Recruiting
Facility Name
Centre Leon Bérard
City
Lyon Cedex 8
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
APHM Hopital Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Name
NKI-AVL, Amsterdam
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Fund. Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Hm Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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