A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

NCT06095089 · tracked via the Priya Life Science USA tracker

Sponsor

Janssen Research & Development, LLC

Phase

Phase 1

Started

2023-11-01

Last updated

2026-08-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

JNJ-78278343JNJ-87189401ApalutamideLutetium Lu-177 Vipivotide TetraxetanJNJ-101556143

JNJ-78278343: JNJ-78278343 will be administered.

JNJ-87189401: JNJ-87189401 will be administered.

Apalutamide: Apalutamide will be administered.

Lutetium Lu-177 Vipivotide Tetraxetan: Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.

JNJ-101556143: JNJ-101556143 will be administered.

Study summary

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.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed * Measurable or evaluable disease per PCWG3 criteria * Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * History of an autoimmune disease within the 12 months prior to signing consent * Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association \[NYHA\] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident

Primary outcome measure(s)

Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) — Up to 21 days after first combination dose of study drugs
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Number of Participants with Adverse Events (AEs) by Severity — Up to 4 years 8 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 (19)

Facility	City	Region	Status
University of Colorado Anschutz Medical Campus	Aurora	Colorado	Recruiting
Emory University Winship Cancer Institute	Atlanta	Georgia	Recruiting
University Of Minnesota	Minneapolis	Minnesota	Recruiting
START New Jersey	East Brunswick	New Jersey	Recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center	New York	New York	Recruiting
Atrium Health Levine Cancer Institute	Charlotte	North Carolina	Recruiting
Oregon Health And Science University	Portland	Oregon	Recruiting
Sidney Kimmel Cancer Center - Jefferson Health	Philadelphia	Pennsylvania	Recruiting
Tennessee Oncology	Nashville	Tennessee	Recruiting
MD Anderson Cancer Center	Houston	Texas	Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)	San Antonio	Texas	Recruiting
Swedish Medical Center	Seattle	Washington	Recruiting
Greenslopes Private Hospital	Greenslopes	Australia	Recruiting
Peter MacCallum Cancer Centre	Melbourne	Australia	Recruiting
The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	China	Recruiting
Institut Bergonie	Bordeaux	France	Recruiting
Centre Leon Berard	Lyon	France	Recruiting
Institut Gustave Roussy	Villejuif	France	Recruiting
The Cancer Institute Hospital of JFCR	Tokyo	Japan	Recruiting

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Other trials for the same condition

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer Active, not recruiting

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer Active, not recruiting

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer Active, not recruiting

A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) Recruiting

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting

Official registry record

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 NCT06095089 on ClinicalTrials.gov ↗ ← All trials in the USA