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| ID | Type | Description | Link |
|---|---|---|---|
| 70218902EDI1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-004885-16 | EudraCT Number | ||
| 2024-516351-40-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
|
| Part 2: Dose Expansion | Experimental | Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-70218902 | Drug | JNJ-70218902 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of JNJ-70218902 | Cmax is the maximum observed serum concentration of JNJ-70218902. | Up to 2.5 years |
| Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Agency - Vancouver BC | Vancouver | British Columbia | V5Z 4E6 | Canada | ||
| Princess Margaret Hospital |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
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Tmax is defined as time to reach maximum observed serum concentration.
| Up to 2.5 years |
| Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902 | AUC(t1-t2) is defined as the area under the serum concentration-time curve from time t1 to t2. | 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. | Up to 2.5 years |
| Minimum Observed Serum Concentration (Cmin) of JNJ-70218902 | Cmin is the minimum observed serum concentration of JNJ-70218902. | 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. | Up to 2.5 years |
| Systemic Cytokine Concentrations | Cytokines concentration will be measured for biomarker assessment. | Up to 2.5 years |
| Serum Prostate Specific Antigen (PSA) Concentration | Serum prostate specific antigen (PSA) concentration will be measured. | Up to 2.5 years |
| Number of Participants With Anti-JNJ-70218902 Antibodies | Number of participants with anti-JNJ-70218902 antibodies will be assessed. | 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). | 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. | Up to 2.5 years |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| Rambam Medical Center | Haifa | 31096 | Israel |
| Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Hosp Univ Vall D Hebron | Barcelona | 08035 | Spain |
| Hosp Univ Fund Jimenez Diaz | Madrid | 28040 | Spain |
| Hosp Univ Hm Sanchinarro | Madrid | 28050 | Spain |
| D000091662 |
| Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |