Recruiting
Phase 1

JNJ-87189401 & JNJ-78278343

Sponsor:

Janssen Research & Development, LLC

Code:

NCT06095089

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-78278343

JNJ-87189401

Apalutamide

Lutetium Lu-177 Vipivotide Tetraxetan

JNJ-101556143

Study Details

Brief 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

Study ID

NCT06095089

Start date

Nov 1, 2023

Status verified date

Aug, 2026

Completion date

Jun 28, 2028

Anticipated

Primary completion date

Jun 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

355 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 (Dose Escalation)

Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R).

experimental: Part 2 (Dose Expansion)

Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet.

experimental: Part 3

Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision.

experimental: Part 4

Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations.

Interventions

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.

Primary outcome measure

  • Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 21 days after first combination dose of study drugs ]
  • Number of Participants with Adverse Events (AEs) by Severity [ Time Frame: Up to 4 years 8 months ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Emory University Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

University Of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Atrium Health Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Oregon Health And Science University

Recruiting

Portland, Oregon, United States, 97239

Sidney Kimmel Cancer Center - Jefferson Health

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

South Texas Accelerated Research Therapeutics, LLC (START)

Recruiting

San Antonio, Texas, United States, 78229

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.