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| ID | Type | Description | Link |
|---|---|---|---|
| 87189401PCR1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2023-504063-17-00 | Registry Identifier | EUCT number |
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The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). |
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| Part 2 (Dose Expansion) | Experimental | Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. |
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| Part 3 | Experimental | Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. |
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| Part 4 | Experimental | Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-78278343 | Drug | JNJ-78278343 will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) | DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. | Up to 21 days after first combination dose of study drugs |
| 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 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by 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 4 years 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentrations of JNJ-87189401 and JNJ-78278343 | Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. | Up to 4 years 8 months |
| Plasma Concentration of JNJ-101556143 |
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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 |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States | |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at 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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| JNJ-87189401 | Drug | JNJ-87189401 will be administered. |
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| Apalutamide | Drug | Apalutamide will be administered. |
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| Lutetium Lu-177 Vipivotide Tetraxetan | Drug | Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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| JNJ-101556143 | Drug | JNJ-101556143 will be administered. |
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Plasma samples will be analyzed to determine concentrations of JNJ-101556143.
| Up to 4 years 8 months |
| Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343 | Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. | Up to 4 years 8 months |
| Objective Response Rate (ORR) | ORR is defined as the proportion 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 Clinical Trials Working Group 3 (PCWG3). | Up to 4 years 8 months |
| Radiographic Progression-Free Survival (rPFS) | rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. | Up to 4 years 8 months |
| Prostate Specific Antigen (PSA) Response Rate | PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. | Up to 4 years 8 months |
| Duration of Response (DOR) | DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first. | Up to 4 years 8 months |
| Emory University Winship Cancer Institute |
| Recruiting |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University Of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| START New Jersey | Recruiting | East Brunswick | New Jersey | 08816 | United States |
| Herbert Irving Comprehensive Cancer Center Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
| Oregon Health And Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Sidney Kimmel Cancer Center - Jefferson Health | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Oncology | Recruiting | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| South Texas Accelerated Research Therapeutics, LLC (START) | Recruiting | San Antonio | Texas | 78229 | United States |
| Swedish Medical Center | Recruiting | Seattle | Washington | 98104 | United States |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | 3000 | Australia |
| Institut Bergonie | Recruiting | Bordeaux | 33000 | France |
| Centre Leon Berard | Recruiting | Lyon | 69008 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94800 | France |
| The Cancer Institute Hospital of JFCR | Recruiting | Tokyo | 135 8550 | Japan |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
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