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Clinical Trials List

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-engaging 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

    2026/08/13

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

本試驗的主要目標是評估針對轉移性去勢抗性攝護腺癌(mCRPC,攝護腺的癌症，位於膀胱下方的一種男性生殖腺體，儘管男性荷爾蒙低仍持續生長)參與者給予 pasrtigamig 合併 docetaxel 治療相較於給予 docetaxel 治療是否能延長放射影像無惡化存活期(rPFS) (自開始治療至由影像判定疾病惡化所經的時間)

Test Drug

靜脈輸注液
靜脈輸注液
錠劑

Active Ingredient

JNJ-78278343 (pasritamig)
DOCETAXEL
PREDNISOLONE

Dosage Form

246
246
110

Dosage

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

Endpoints

1.盲性獨立中央評估委員會 (BICR)評估的放射影像無惡化存活期 (rPFS)
由BICR評估rPFS，定義為自隨機分配起至評估為放射影像惡化或因任何原因死亡的時間，以先發生者為準。
[時間：至多約1年10個月]

Inclution Criteria

Inclusion criteria:

Have histologically confirmed adenocarcinoma of the prostate
Have disease that is metastatic at the time of screening by computed tomography (CT) or magnetic resonance imaging (MRI) and 99m^Tc bone scan 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 deciliter (ng/dL) (<= 1.73 nanomoles per Liter [nmol/L]) at screening
Have progressed by PSA or CT/MRI or 99m^Tc bone scan on at least 1 novel androgen receptor pathway inhibition (ARPI) but 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)
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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