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Protocol Number78278343PCR3003
NCT Number(ClinicalTrials.gov Identfier)NCT07225946
Active

2025-11-01 - 2030-12-31

Phase III

Recruiting5

A Phase 3 Randomized, Open-label Study of Pasritamig (JNJ-78278343), a T-cell-redirecting Agent Targeting Human Kallikrein 2, With Docetaxel Versus Docetaxel for Metastatic Castration-resistant Prostate Cancer

  • Trial Applicant

    Johnson & Johnson

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/02

Investigators and Locations

Principal Investigator Kai-Jie Yu Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hsi-Chin Wu Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shian-Shiang Wang Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 歐宴泉 Division of Urology
童綜合醫療社團法人童綜合醫院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Pin Su
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Prostatic Neoplasms, Castration-Resistant

Objectives

The primary objective of this trial was to evaluate whether treatment with pasrtigamig combined with docetaxel in participants with metastatic castration-resistant prostate cancer (mCRPC, cancer of the prostate, a male reproductive gland located below the bladder that continues to grow despite low androgen levels) compared to treatment with docetaxel alone prolonged radiographic progression-free survival (rPFS) (the time from the start of treatment to radiographically determined disease progression).

Test Drug

Intravenous infusion solution
Intravenous infusion solution
Tablets

Active Ingredient

JNJ-78278343 (pasritamig)
DOCETAXEL
PREDNISOLONE

Dosage Form

246
246
110

Dosage

18mg/3.6ml
80mg/4ml
5 mg

Endpoints

1. Radiographic Progression-Free Survival (rPFS) assessed by the Blinded Independent Central Evaluation Committee (BICR) rPFS, assessed by BICR, is defined as the time from randomization to the assessment of radiographic progression or death from any cause, whichever comes first.

[Time: Up to approximately 1 year and 10 months]

Inclution Criteria

Inclusion criteria:

Have histologically confirmed adenocarcinoma of the prostate
Have disease that is metastatic at the time of the screening as determined by the investigator
Participants must receive ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone (GnRH) analog throughout the treatment or have had prior bilateral orchiectomy, and have serum testosterone less than or equal to (<=) 50 nanogram per milliliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening
Have progressed on at least 1 novel androgen receptor pathway inhibition (ARPI) but received no more than 2 different ARPI for any stage of disease. Must have discontinued ARPI before randomization into the study
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Exclusion Criteria

Exclusion criteria:

Known history of either brain or leptomeningeal prostate cancer metastases
Participants with known breast cancer gene 1/2 (BRCA 1/2) mutations (germline or somatic) who have not received treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor, unless not available or contraindicated
Prior or concurrent second malignancy (other than the disease under study) because the natural history or treatment could interfere with study endpoints
Received cytotoxic chemotherapy for prostate cancer in any setting
Received prior treatment with human kallikrein 2 (KLK-2) directed therapies

The Estimated Number of Participants

  • Taiwan

    35 participants

  • Global

    800 participants

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