Prostatic Neoplasms
Conditions
Keywords
Metastatic castration-resistant prostate cancer (mCRPC), Advanced prostate cancer
Brief summary
The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).
Interventions
DRUGJNJ-78278343
JNJ-78278343 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed adenocarcinoma of the prostate which has spread to other body parts * Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy * Measurable or evaluable disease * Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog
Exclusion criteria
Disease conditions * Active central nervous system (CNS) involvement * Toxicity related to prior anticancer therapy has not adequately recovered Prior/Concomitant Therapy * Prior treatment with human kallikrein (KLK) 2-targeted therapy * Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug * Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug Prior/Concurrent Medical Conditions * Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug * Solid organ or bone marrow transplantation * Major clotting diseases within one month prior to the first dose of study drug * Active autoimmune disease within 12 months prior to the first dose of study drug * Active infection * Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug * Clinically significant lung diseases * Active or chronic hepatitis B or hepatitis C infection * Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load) * Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and 2: Number of Participants With Adverse Events (AEs) | Up to 1 year and 10 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. |
| Part 1 and 2: Number of Participants With AEs by Severity | Up to 1 year and 10 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 immune effector cell associated neurotoxicity syndrome (ICANS) 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 1 year and 10 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 Concentration of JNJ-78278343 | Up to 1 year and 10 months | Serum concentrations of JNJ-78278343 will be determined. |
| Systemic Cytokine Concentrations | Up to 1 year and 10 months | Cytokine concentrations will be determined for biomarker assessment. |
| Serum Prostate Specific Antigen (PSA) Concentration | Up to 1 year and 10 months | Serum PSA concentration will be measured. |
| Number of Participants With Anti-JNJ-78278343 Antibodies | Up to 1 year and 10 months | Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method. |
| Objective Response Rate (ORR) | Up to 1 year and 10 months | ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3). |
| Radiographic Progression-free Survival (rPFS) | Up to 1 year and 10 months | rPFS is defined as time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first. |
| PSA Response Rate | Up to 1 year and 10 months | PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment. |
| Duration of Response (DOR) | Up to 1 year and 10 months | DOR will be calculated among responders (PR or better) 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 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first. |
Countries
China, France, Japan, Netherlands, Spain, United States
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed