Prostatic Neoplasms
Conditions
Keywords
Prostate cancer
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).
Interventions
DRUGJNJ-80038114
JNJ-80038114 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Prostate Specific Antigen (PSA) Concentration | Up to 2 Years 6 Months | Serum PSA concentration will be determined. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United Kingdom, United States
Outcome results
None listed