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| ID | Type | Description | Link |
|---|---|---|---|
| 78278343PCR1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-503132-14-00 | Registry Identifier | EUCT number |
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The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) | Experimental | Participants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343) and combination agent treatment at the putative RP2R in Part 2 (dose expansion). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasritamig | Drug | Pasritamig will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicity (DLT) | 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 after first dose of combination agent |
| Part 1 and Part 2: 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 2 years 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria. | Up to 2 years 11 months |
| Prostate Specific Antigen (PSA) Response Rate |
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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 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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| Cetrelimab | Drug | Cetrelimab will be administered by intravenous infusion. |
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| Cabazitaxel | Drug | Cabazitaxel will be administered by intravenous infusion. |
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| Docetaxel | Drug | Docetaxel will be administered by intravenous infusion. |
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| Apalutamide | Drug | Apalutamide will be administered orally. |
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| Enzalutamide | Drug | Enzalutamide will be administered orally. |
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| Darolutamide | Drug | Darolutamide will be administered orally. |
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| Abiraterone acetate plus prednisone (AAP) | Drug | Abiraterone acetate plus prednisone (AAP) will be administered orally. |
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| Lutetium Lu-177 vipivotide tetraxetan | Drug | Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously. |
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| JNJ-101556143 | Drug | JNJ-101556143 will be administered orally. |
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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 2 years 11 months |
| Radiographic Progression-free Survival (rPFS) | rPFS is defined time from the date of first dose of pasritamig until the date of objective disease progression or death, whichever comes first. | Up to 2 years 11 months |
| Time to Response (TTR) | TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed. | Up to 2 years 11 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 2 years 11 months |
| Part 2H Metastatic hormone-sensitive prostate cancer (mHSPC) Participants : Composite Progression-Free Survival (PFS) | Composite PFS is defined as time from start of treatment to the date of first occurrence of investigator determined disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] or bone progression), pain, PSA progression, death or last disease assessment. | Up to 2 years 11 months |
| Start Midwest |
| Recruiting |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| Washington University School Of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Perlmutter Cancer Center at NYU Langone Brooklyn | Recruiting | Brooklyn | New York | 11223 | United States |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Recruiting | Mineola | New York | 11501 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| Sidney Kimmel Cancer Center - Jefferson Health | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Icon Cancer Centre Kurralta Park | Recruiting | Kurralta Park | 5037 | Australia |
| Macquarie University | Recruiting | Macquarie University | 2109 | Australia |
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | 3000 | Australia |
| Princess Alexandra Hospital | Recruiting | Woolloongabba | 4102 | Australia |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 8035 | Spain |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hosp. Univ. 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hosp Univ Hm Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| C552428 | cabazitaxel |
| D000077143 | Docetaxel |
| C572045 | apalutamide |
| C540278 | enzalutamide |
| C000607739 | darolutamide |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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