A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Pasritamig: Pasritamig will be administered.
Cetrelimab: Cetrelimab will be administered by intravenous infusion.
Cabazitaxel: Cabazitaxel will be administered by intravenous infusion.
Docetaxel: Docetaxel will be administered by intravenous infusion.
Apalutamide: Apalutamide will be administered orally.
Enzalutamide: Enzalutamide will be administered orally.
Darolutamide: Darolutamide will be administered orally.
Abiraterone acetate plus prednisone (AAP): Abiraterone acetate plus prednisone (AAP) will be administered orally.
Lutetium Lu-177 vipivotide tetraxetan: Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
JNJ-101556143: JNJ-101556143 will be administered orally.
Study summary
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).
Eligibility
Primary outcome measure(s)
- Part 1: Number of Participants With Dose Limiting Toxicity (DLT) — Up to 21 days after first dose of combination agent
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. - Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity — Up to 2 years 11 months
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.
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Start Midwest | Grand Rapids | Michigan | Recruiting |
| Washington University School Of Medicine | St Louis | Missouri | Recruiting |
| Perlmutter Cancer Center at NYU Langone Brooklyn | Brooklyn | New York | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island | Mineola | New York | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| Sidney Kimmel Cancer Center - Jefferson Health | Philadelphia | Pennsylvania | Recruiting |
| Icon Cancer Centre Kurralta Park | Kurralta Park | Australia | Recruiting |
| Macquarie University | Macquarie University | Australia | Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Australia | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Australia | Recruiting |
| Hosp Univ Vall D Hebron | Barcelona | Spain | Recruiting |
| Hosp Univ Fund Jimenez Diaz | Madrid | Spain | Recruiting |
| Hosp. Univ. 12 de Octubre | Madrid | Spain | Recruiting |
| Hosp Univ Hm Sanchinarro | Madrid | Spain | Recruiting |
On this site
📄 Xtandi (enzalutamide) drug profile →More Janssen Research & Development, LLC trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05818683 on ClinicalTrials.gov ↗ ← All trials in Spain