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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
JNJ-70218902 will be administered.
BC Cancer Agency - Vancouver BC
Vancouver, British Columbia, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Rambam Medical Center
Haifa, Israel
Sourasky Medical Center
Tel Aviv, Israel
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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.
Time frame: Up to 2.5 years
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
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.
Time frame: Up to 21 days
Part 1 and Part 2: Number of Participants with AEs by Severity
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.
Time frame: Up to 2.5 years
Maximum Observed Serum Concentration (Cmax) of JNJ-70218902
Cmax is the maximum observed serum concentration of JNJ-70218902.
Time frame: Up to 2.5 years
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902
Tmax is defined as time to reach maximum observed serum concentration.
Time frame: Up to 2.5 years
Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902
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Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Hosp Univ Hm Sanchinarro
Madrid, Spain
AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2.
Time frame: Up to 2.5 years
Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902
AUCtau is the measure of the serum drug concentration from time zero to end of dosing interval.
Time frame: Up to 2.5 years
Minimum Observed Serum Concentration (Cmin) of JNJ-70218902
Cmin is the minimum observed serum concentration of JNJ-70218902.
Time frame: Up to 2.5 years
Accumulation Ratio (RA) of JNJ-70218902
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.
Time frame: Up to 2.5 years
Systemic Cytokine Concentrations
Cytokines concentration will be measured for biomarker assessment.
Time frame: Up to 2.5 years
Serum Prostate Specific Antigen (PSA) Concentration
Serum prostate specific antigen (PSA) concentration will be measured.
Time frame: Up to 2.5 years
Number of Participants With Anti-JNJ-70218902 Antibodies
Number of participants with anti-JNJ-70218902 antibodies will be assessed.
Time frame: Up to 2.5 years
Objective Response Rate (ORR)
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).
Time frame: Up to 2.5 years
Duration of Response (DOR)
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.
Time frame: Up to 2.5 years