Back to resultsA Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer
Primary Purpose
Metastatic Castration-resistant Prostate Neoplasms
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
JNJ-78278343
Cetrelimab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-resistant Prostate Neoplasms
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. Prior treatment for mCRPC with at least 1 prior novel androgen receptor-targeted therapy (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate organ functions Exclusion Criteria: Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy) Solid organ or bone marrow transplantation Known allergies, hypersensitivity, or intolerance to any of the components (eg, excipients) of JNJ-78278343 or cetrelimab Significant infections or serious lung, heart or other medical conditions
Sites / Locations
- Florida Cancer SpecialistsRecruiting
- Start MidwestRecruiting
- Macquarie UniversityRecruiting
- Peter MacCallum Cancer CentreRecruiting
- Princess Alexandra HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Arm Description
Participants will receive subcutaneous (SC) administration of JNJ-78278343 in combination with intravenous (IV) infusion of cetrelimab during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 dose (RP2D). Participants will receive the combination treatment at the RP2D in Part 2 (dose expansion)
Outcomes
Primary Outcome Measures
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events 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
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
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
NCT05818683
First Posted
April 6, 2023
Last Updated
October 9, 2023
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05818683
Brief Title
A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer
Official Title
A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to identify the recommended phase 2 doses (RP2Ds) of JNJ-78278343 with cetrelimab (JNJ-63723283) in Part 1 (dose escalation) and to determine 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
Metastatic Castration-resistant Prostate Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (SC) administration of JNJ-78278343 in combination with intravenous (IV) infusion of cetrelimab during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 dose (RP2D). Participants will receive the combination treatment at the RP2D in Part 2 (dose expansion)
Intervention Type
Drug
Intervention Name(s)
JNJ-78278343
Intervention Description
JNJ-78278343 will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Cetrelimab
Other Intervention Name(s)
JNJ-63723283
Intervention Description
Cetrelimab will be administered by intravenous infusion.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Description
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 21 days after first dose of cetrelimab
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
Up to 2 years 10 months
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Time Frame
Up to 2 years 10 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 2 years 10 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 2 years 10 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.
Prior treatment for mCRPC with at least 1 prior novel androgen receptor-targeted therapy (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions
Exclusion Criteria:
Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
Solid organ or bone marrow transplantation
Known allergies, hypersensitivity, or intolerance to any of the components (eg, excipients) of JNJ-78278343 or cetrelimab
Significant infections or serious 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
Florida Cancer Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Individual Site Status
Recruiting
Facility Name
Start Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Macquarie University
City
Macquarie University
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
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 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer
We'll reach out to this number within 24 hrs