search
Back to results

A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-80038114
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 Prostate cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
  • Measurable or evaluable disease
  • At least 1 prior treatment for mCRPC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ functions as defined by certain laboratory values
  • Must sign an informed consent form (ICF)
  • Participants must agree to use a highly effective form of birth control as guided by the study doctor

Exclusion Criteria:

  • Concurrent anticancer therapy
  • Severe or long-lasting side effects related to prior anticancer therapy
  • Known allergies to JNJ-80038114 or its excipients
  • Brain metastasis or known seizure history
  • Significant infections or lung, heart or other medical conditions

Sites / Locations

  • University Of MinnesotaRecruiting
  • Sidney Kimmel Cancer Center - Jefferson HealthRecruiting
  • Sarah Cannon Research InstituteRecruiting
  • University College London Hospitals NHSFTRecruiting
  • The Christie NHS Foundation Trust - Christie HospitalRecruiting
  • Royal Marsden HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part 1: Dose Escalation

Part 2: Dose Expansion

Arm Description

Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).

Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Outcomes

Primary Outcome Measures

Parts 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.
Parts 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 associated neurologic toxicity events 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-80038114
Serum concentration of JNJ-80038114 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 determined.
Number of Participants With Antibodies to JNJ-80038114
Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 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 Prostate Cancer Working Group 3 (PCWG3) response criteria.
PSA Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline.
Duration of Response (DOR)
DOR is defined as the duration 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 response criteria, or death due to any cause, whichever occurs first.

Full Information

First Posted
June 28, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT05441501
Brief Title
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
Official Title
A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
March 21, 2025 (Anticipated)
Study Completion Date
March 21, 2025 (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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1: Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).
Arm Title
Part 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.
Intervention Type
Drug
Intervention Name(s)
JNJ-80038114
Intervention Description
JNJ-80038114 will be administered.
Primary Outcome Measure Information:
Title
Parts 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 2 Years 6 Months
Title
Parts 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 associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Time Frame
Up to 2 Years 6 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 2 Years 6 Months
Secondary Outcome Measure Information:
Title
Serum Concentration of JNJ-80038114
Description
Serum concentration of JNJ-80038114 will be determined.
Time Frame
Up to 2 Years 6 Months
Title
Systemic Cytokine Concentrations
Description
Cytokine concentrations will be determined for biomarker assessment.
Time Frame
Up to 2 Years 6 Months
Title
Serum Prostate Specific Antigen (PSA) Concentration
Description
Serum PSA concentration will be determined.
Time Frame
Up to 2 Years 6 Months
Title
Number of Participants With Antibodies to JNJ-80038114
Description
Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method.
Time Frame
Up to 2 Years 6 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 Prostate Cancer Working Group 3 (PCWG3) response criteria.
Time Frame
Up to 2 Years 6 Months
Title
PSA Response Rate
Description
PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline.
Time Frame
Up to 2 Years 6 Months
Title
Duration of Response (DOR)
Description
DOR is defined as the duration 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 response criteria, or death due to any cause, whichever occurs first.
Time Frame
Up to 2 Years 6 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3) Measurable or evaluable disease At least 1 prior treatment for mCRPC Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ functions as defined by certain laboratory values Must sign an informed consent form (ICF) Participants must agree to use a highly effective form of birth control as guided by the study doctor Exclusion Criteria: Concurrent anticancer therapy Severe or long-lasting side effects related to prior anticancer therapy Known allergies to JNJ-80038114 or its excipients Brain metastasis or known seizure history Significant infections or lung, heart or other medical conditions
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
University Of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Sidney Kimmel Cancer Center - Jefferson Health
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
University College London Hospitals NHSFT
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Christie NHS Foundation Trust - Christie Hospital
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
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-80038114 in Participants With Advanced Stage Prostate Cancer

We'll reach out to this number within 24 hrs