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Clinical Trials in Japan / NCT06095089
Recruiting Phase 1

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

NCT06095089 · tracked via the Priya Life Science Japan tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2023-11-01
Last updated
2026-09-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

JNJ-78278343 →JNJ-87189401 →Apalutamide →Lutetium Lu-177 Vipivotide Tetraxetan →JNJ-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
No
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 (20)

FacilityCityRegionStatus
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
Chongqing University Cancer Hospital Chongqing China 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

More Janssen Research & Development, LLC trials in Japan

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Recruiting
A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC) Recruiting
A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting

Other trials for the same condition

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
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Active, not recruiting
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) Recruiting
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) Recruiting
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy 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 Japan