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| ID | Type | Description | Link |
|---|---|---|---|
| 63898081EDI1001 | Other Identifier | Janssen Research & Development, LLC |
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The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.
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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-63898081. Ascending dose levels will be sequentially tested. |
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| Part 2: Dose Expansion | Experimental | Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-63898081 | Drug | JNJ-63898081 will be administered. |
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| 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. | Approximately 3 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. | Approximately 3 years |
| Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) | Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death. | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 and Part 2: Serum Concentrations of JNJ-63898081 | Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method. | Approximately 3 years |
| Part 1 and 2: Systemic Cytokine Concentrations |
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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 |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States | ||
| NIH Clinical Center |
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 |
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A panel of cytokines, including those proinflammatory ones, will be measured.
| Approximately 3 years |
| Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies | Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants. | Approximately 3 years |
| Serum Prostate Specific Antigen (PSA) Concentration | Serum prostate specific antigen (PSA) concentration will be assessed. | Approximately 3 years |
| Objective Response Rate (ORR) | ORR is defined as the proportion of participants who have a PR or better according to the disease-specific response criteria. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3). | Approximately 3 years |
| Duration of Response | 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 disease-specific response criteria, or death due to any cause, whichever occurs first. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3). | Approximately 3 years |
| Bethesda |
| Maryland |
| 20892 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| University of Washington | Seattle | Washington | 98195-9472 | United States |
| British Columbia Cancer Agency | Vancouver | British Columbia | V5Z4E6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |