Neoplasms
Conditions
Keywords
metastatic Castration-Resistant Prostate Cancer (mCRPC), Prostate Cancer
Brief summary
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.
Detailed description
JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.
Interventions
DRUGJNJ-70218902
JNJ-70218902 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
* Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed * Measurable or evaluable disease * Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy * If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Adequate organs functions
Exclusion criteria
* Known brain metastases * Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease * Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (\<=) 1 or baseline, except for alopecia and vitiligo * Solid organ or bone marrow transplantation * Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients * Certain comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 2.5 years | 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: Number of Participants with Dose-Limiting Toxicity (DLT) | Up to 21 days | Number of participants with DLT will be assessed. The 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 AEs by Severity | Up to 2.5 years | 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), which will be graded according to the 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of JNJ-70218902 | Up to 2.5 years | Cmax is the maximum observed serum concentration of JNJ-70218902. |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902 | Up to 2.5 years | Tmax is defined as time to reach maximum observed serum concentration. |
| Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902 | Up to 2.5 years | AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2. |
| Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902 | Up to 2.5 years | AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval. |
| Minimum Observed Serum Concentration (Cmin) of JNJ-70218902 | Up to 2.5 years | Cmin is the minimum observed serum concentration of JNJ-70218902. |
| Accumulation Ratio (RA) of JNJ-70218902 | Up to 2.5 years | Accumulation Ratio (RA) is calculated as area under the plasma concentration-time curve from time zero to 24 hours (AUC \[0-24\]) value at steady state divided by AUC (0-24) value after first dose. |
| Systemic Cytokine Concentrations | Up to 2.5 years | Cytokines concentration will be measured for biomarker assessment. |
| Serum Prostate Specific Antigen (PSA) Concentration | Up to 2.5 years | Serum prostate specific antigen (PSA) concentration will be measured. |
| Number of Participants With Anti-JNJ-70218902 Antibodies | Up to 2.5 years | Number of participants with anti-JNJ-70218902 antibodies will be assessed. |
| Objective Response Rate (ORR) | Up to 2.5 years | ORR is defined as the percentage of participants who have a Partial Response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3). |
| Duration of Response (DOR) | Up to 2.5 years | Duration of response (DOR) will be calculated 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
Canada, Israel, Spain
Contacts
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed