A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Dose Escalation 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). |
Drug: JNJ-80038114
JNJ-80038114 will be administered.
|
| Experimental: Part 2: Dose Expansion Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
Drug: JNJ-80038114
JNJ-80038114 will be administered.
|
Outcome Measures
Primary Outcome Measures
- Parts 1 and 2: Number of Participants With Adverse Events (AEs) [Up to 2 Years 6 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.
- Parts 1 and 2: Number of Participants With AEs by Severity [Up to 2 Years 6 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) 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) [Up to 2 Years 6 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
- Serum Concentration of JNJ-80038114 [Up to 2 Years 6 Months]
Serum concentration of JNJ-80038114 will be determined.
- Systemic Cytokine Concentrations [Up to 2 Years 6 Months]
Cytokine concentrations will be determined for biomarker assessment.
- Serum Prostate Specific Antigen (PSA) Concentration [Up to 2 Years 6 Months]
Serum PSA concentration will be determined.
- Number of Participants With Antibodies to JNJ-80038114 [Up to 2 Years 6 Months]
Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method.
- Objective Response Rate (ORR) [Up to 2 Years 6 Months]
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 [Up to 2 Years 6 Months]
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) [Up to 2 Years 6 Months]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 2 | Centre Leon Bérard | Lyon | France | 69008 | |
| 3 | CHU de la Timone | Marseille | France | 13005 | |
| 4 | Gustave Roussy | Villejuif | France | 94800 | |
| 5 | Universitätsklinikum Düsseldorf | Düsseldorf | Germany | 40225 | |
| 6 | Universitatsklinikum Freiburg | Freiburg | Germany | 79106 | |
| 7 | University College London Hospitals NHSFT | London | United Kingdom | NW1 2PG | |
| 8 | The Christie NHS Foundation Trust - Christie Hospital | Manchester | United Kingdom | M20 4BX | |
| 9 | Royal Marsden Hospital | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109209
- 80038114PCR1001