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NCT Number: NCT06095089

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre, Melbourne, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-78278343

Drug

JNJ-78278343 will be administered.

Other names: KLK2-CD3, Pasritamig

JNJ-87189401

Drug

JNJ-87189401 will be administered.

Other names: PSMAxCD28

Apalutamide

Drug

Apalutamide will be administered.

Lutetium Lu-177 vipivotide tetraxetan

Drug

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

JNJ-101556143

Drug

JNJ-101556143 will be administered.

Other names: HLD-0915

Primary outcomes

  1. 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

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

  2. Number of Participants with Adverse Events (AEs) by Severity

    Time frame: Up to 4 years 8 months

    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.

Secondary outcomes

  1. Serum Concentrations of JNJ-87189401 and JNJ-78278343

    Time frame: Up to 4 years 8 months

    Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343.

  2. Plasma Concentration of JNJ-101556143

    Time frame: Up to 4 years 8 months

    Plasma samples will be analyzed to determine concentrations of JNJ-101556143.

  3. Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343

    Time frame: Up to 4 years 8 months

    Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.

  4. Objective Response Rate (ORR)

    Time frame: Up to 4 years 8 months

    ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3).

  5. Radiographic Progression-Free Survival (rPFS)

    Time frame: Up to 4 years 8 months

    rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first.

  6. Prostate Specific Antigen (PSA) Response Rate

    Time frame: Up to 4 years 8 months

    PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.

  7. Duration of Response (DOR)

    Time frame: Up to 4 years 8 months

    DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 23, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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