A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
- Conditions
- Prostatic Neoplasms
- Interventions
- Drug: JNJ-80038114
- Registration Number
- NCT05441501
- Lead Sponsor
- Janssen Research & Development, LLC
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation JNJ-80038114 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). Part 2: Dose Expansion JNJ-80038114 Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Serum Prostate Specific Antigen (PSA) Concentration Up to 2 Years 6 Months Serum PSA concentration will be determined.
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.
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.
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.
Trial Locations
- Locations (6)
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
University Of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Sidney Kimmel Cancer Center - Jefferson Health
🇺🇸Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
University College London Hospitals NHSFT
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust Christie Hospital
🇬🇧Manchester, United Kingdom