Back to resultsA Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
Primary Purpose
Advanced Prostate Cancer
Status
Not yet recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-78278343
JNJ-87189401
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Prostate Cancer
Eligibility Criteria
Inclusion Criteria: Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate Cancer Working Group 3 (PCWG3): Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed Measurable or evaluable disease per PCWG3 criteria; all participants must have a serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at time of screening Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus) Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Sites / Locations
- Centre Leon Bérard
- Institut Gustave Roussy
- Erasmus MC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Arm Description
Participants will receive JNJ-78278343+JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). Participants will receive the combination treatment at the RP2R in Part 2 (dose expansion).
Outcomes
Primary Outcome Measures
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Secondary Outcome Measures
Part 2: Serum Concentration of JNJ-87189401
Serum samples will be analyzed to determine concentrations of JNJ-87189401.
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3).
Prostate Specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Duration of Response (DOR)
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Full Information
NCT ID
NCT06095089
First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT06095089
Brief Title
A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
Official Title
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 10, 2023 (Anticipated)
Primary Completion Date
June 21, 2027 (Anticipated)
Study Completion Date
June 21, 2027 (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 the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Arm Type
Experimental
Arm Description
Participants will receive JNJ-78278343+JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). Participants will receive the combination treatment at the RP2R in Part 2 (dose expansion).
Intervention Type
Drug
Intervention Name(s)
JNJ-78278343
Other Intervention Name(s)
KLK2-CD3
Intervention Description
JNJ-78278343 will be administered.
Intervention Type
Drug
Intervention Name(s)
JNJ-87189401
Other Intervention Name(s)
PSMAxCD28
Intervention Description
JNJ-87189401 will be administered.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Description
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Time Frame
Up to 21 days after first combination dose of study drugs
Title
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Time Frame
3 years 7 months
Secondary Outcome Measure Information:
Title
Part 2: Serum Concentration of JNJ-87189401
Description
Serum samples will be analyzed to determine concentrations of JNJ-87189401.
Time Frame
Up to 3 years 7 months
Title
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Description
Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.
Time Frame
Up to 3 years 7 months
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3).
Time Frame
Up to 3 years 7 months
Title
Prostate Specific Antigen (PSA) Response Rate
Description
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Time Frame
Up to 3 years 7 months
Title
Duration of Response (DOR)
Description
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Time Frame
Up to 3 years 7 months
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate Cancer Working Group 3 (PCWG3): Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
Measurable or evaluable disease per PCWG3 criteria; all participants must have a serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at time of screening
Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
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
Centre Leon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
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-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
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