A Phase 1 interventional study of Pasritamig and JNJ-86974680 in Prostatic Neoplasms, sponsored by Janssen Research & Development, LLC. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
Exclusion criteria:
Participants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen.
Drug: Pasritamig · Drug: JNJ-86974680
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.
Drug: Pasritamig · Drug: JNJ-86974680
Pasritamig will be administered intravenously.
Also known as: JNJ-78278343
JNJ-86974680 will be administered orally.
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.
Time frame: 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.
Time frame: Up To Day 22
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).
Time frame: Up to 1 year 2 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year 2 months
Serum Concentration of Pasritamig
Serum samples will be analyzed to determine concentrations of pasritamig.
Time frame: Up to 1 year 2 months
Plasma Concentration of JNJ-86974680
Plasma samples will be analyzed to determine concentrations of JNJ-86974680.
Time frame: 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.
Time frame: Up to 1 year 2 months
Plan to share: Yes — 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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