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

NCT06095089 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: CR10933087189401PCR10012023-504063-17-00
• Study Type: interventional
• Target: 355
• Locations: 3 countries
• Sites: 13

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

Outcome Measures

Primary Outcomes (2)

• Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)

  DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

  Up to 21 days after first combination dose of study drugs

• Number of Participants with Adverse Events (AEs) by Severity

  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.

  Up to 4 years 8 months

Secondary Outcomes (7)

• Serum Concentrations of JNJ-87189401 and JNJ-78278343

  Up to 4 years 8 months

• Plasma Concentration of JNJ-101556143

  Up to 4 years 8 months

• Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343

  Up to 4 years 8 months

• Objective Response Rate (ORR)

  Up to 4 years 8 months

• Radiographic Progression-Free Survival (rPFS)

  Up to 4 years 8 months

Study Arms (4)

Part 1 (Dose Escalation)

EXPERIMENTAL

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

Drug: JNJ-78278343; Drug: JNJ-87189401

Part 2 (Dose Expansion)

EXPERIMENTAL

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.

Drug: JNJ-78278343; Drug: JNJ-87189401; Drug: Apalutamide

Part 3

EXPERIMENTAL

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.

Drug: JNJ-78278343; Drug: JNJ-87189401; Drug: Lutetium Lu-177 Vipivotide Tetraxetan

Part 4

EXPERIMENTAL

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.

Drug: JNJ-78278343; Drug: JNJ-87189401; Drug: JNJ-101556143

Interventions

JNJ-78278343 DRUG

JNJ-78278343 will be administered.

Also known as: KLK2-CD3, Pasritamig

Part 1 (Dose Escalation); Part 2 (Dose Expansion); Part 3; Part 4

JNJ-87189401 DRUG

JNJ-87189401 will be administered.

Also known as: PSMAxCD28

Part 1 (Dose Escalation); Part 2 (Dose Expansion); Part 3; Part 4

Apalutamide DRUG

Apalutamide will be administered.

Part 2 (Dose Expansion)

Lutetium Lu-177 Vipivotide Tetraxetan DRUG

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

Part 3

JNJ-101556143 DRUG

JNJ-101556143 will be administered.

Also known as: HLD-0915

Part 4

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

START New Jersey

East Brunswick, New Jersey, 08816, United States

RECRUITING

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Oregon Health And Science University

Portland, Oregon, 97239, United States

RECRUITING

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, 78229, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Institut Bergonie

Bordeaux, 33000, France

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

The Cancer Institute Hospital of JFCR

Tokyo, 135 8550, Japan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): June 21, 2027
• Study Completion (Estimated): June 28, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); FR (3); JP (1)