Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

NCT ID: NCT06095089Sponsor: Janssen Research & Development, LLCLast updated: 2026-06-05

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.

Arms & interventions

  • DrugJNJ-78278343

    JNJ-78278343 will be administered.

  • DrugJNJ-87189401

    JNJ-87189401 will be administered.

  • DrugApalutamide

    Apalutamide will be administered.

  • DrugLutetium Lu-177 Vipivotide Tetraxetan

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

  • DrugJNJ-101556143

    JNJ-101556143 will be administered.

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: Up to 4 years 8 months

Secondary

  • Serum Concentrations of JNJ-87189401 and JNJ-78278343

    Time frame: Up to 4 years 8 months

  • Plasma Concentration of JNJ-101556143

    Time frame: Up to 4 years 8 months

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

    Time frame: Up to 4 years 8 months

  • Objective Response Rate (ORR)

    Time frame: Up to 4 years 8 months

  • Radiographic Progression-Free Survival (rPFS)

    Time frame: Up to 4 years 8 months

  • Prostate Specific Antigen (PSA) Response Rate

    Time frame: Up to 4 years 8 months

  • Duration of Response (DOR)

    Time frame: Up to 4 years 8 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy 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

Study locations (11)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

Recruiting

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322

Recruiting

University Of Minnesota

Minneapolis, Minnesota, 55455

Recruiting

START New Jersey

East Brunswick, New Jersey, 08816

Recruiting

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, 10032

Recruiting

Oregon Health And Science University

Portland, Oregon, 97239

Recruiting

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, 19107

Recruiting

Tennessee Oncology

Nashville, Tennessee, 37203

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

South Texas Accelerated Research Therapeutics, LLC (START)

San Antonio, Texas, 78229

Recruiting

Swedish Medical Center

Seattle, Washington, 98104

Recruiting