A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Pasritamig: Pasritamig will be administered intravenously.
JNJ-86974680: JNJ-86974680 will be administered orally.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number of Participants With Adverse Events (AEs) by Severity — Up to 1 year 2 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. 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. - Part 1: Number of Participants With Dose-Limiting Toxicity (DLT) — Up To Day 22
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Florida Cancer Specialists | Sarasota | Florida | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| The Christie NHS Foundation Trust Christie Hospital | Manchester | United Kingdom | Recruiting |
| Royal Marsden Hospital | Sutton | United Kingdom | Recruiting |
More Janssen Research & Development, LLC trials in the UK
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 NCT07319871 on ClinicalTrials.gov ↗ ← All trials in the UK