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

NCT06095089 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2026-05-04

No results posted yet for this 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.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

JNJ-78278343

JNJ-78278343 will be administered.

DRUG

JNJ-87189401

JNJ-87189401 will be administered.

DRUG

Apalutamide

Apalutamide will be administered.

DRUG

Lutetium Lu-177 Vipivotide Tetraxetan

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

DRUG

JNJ-101556143

JNJ-101556143 will be administered.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2027-06-21
Completion
2028-06-28
FDA Drug
Yes

Countries

  • United States
  • France
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095089 on ClinicalTrials.gov