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
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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