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| ID | Type | Description | Link |
|---|---|---|---|
| 78278343PBPCR1005 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Finding | Experimental | Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen. |
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| Part 2: Dose Expansion | Experimental | Participants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasritamig | Drug | Pasritamig will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) by Severity | 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. 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 and ocular events will be graded using the alternative scale provided in the protocol. | Up to 1 year 2 months |
| Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) | High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT. | Up To Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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). | Up to 1 year 2 months |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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 |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| JNJ-86974680 | Drug | JNJ-86974680 will be administered orally. |
|
| Prostate-Specific Antigen (PSA) Response Rate |
PSA response rate is defined as the percentage of participants with a decline of PSA of 50% or more from baseline. |
| Up to 1 year 2 months |
| Duration of Response (DOR) | 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. | Up to 1 year 2 months |
| Radiographic Progression-Free Survival (rPFS) | rPFS is defined as the time from the date of first dose of pasritamig or JNJ-86974680 until the date of radiographic disease progression or death, whichever comes first. | Up to 1 year 2 months |
| Time to Response (TTR) | TTR is defined for the responders as the time from the date of first dose of any study treatment to the date of first documented response. | Up to 1 year 2 months |
| Serum Concentration of Pasritamig | Serum samples will be analyzed to determine concentrations of pasritamig. | Up to 1 year 2 months |
| Plasma Concentration of JNJ-86974680 | Plasma samples will be analyzed to determine concentrations of JNJ-86974680. | Up to 1 year 2 months |
| Number of Participants With Anti-Pasritamig Antibodies | Serum samples will be analyzed for the detection of anti-pasritamig antibodies using a validated assay method. | Up to 1 year 2 months |
| Columbia University Medical Center |
| Recruiting |
| New York |
| New York |
| 10032 |
| United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| The Christie NHS Foundation Trust Christie Hospital | Recruiting | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital | Recruiting | Sutton | SM2 5PT | United Kingdom |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |