Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Janssen Research & Development, LLC (Voir sur ClinicalTrials)
décembre 2025
juillet 2029
31 juillet 2026
The purpose of this study is to find out whether treatment with pasritamig and docetaxel
prolongs radiographic progression free survival (rPFS) (the length of time from start of
treatment until disease worsens as determined by scans or death due to any cause) when
compared to treatment with docetaxel in participants with metastatic castrate-resistant
prostate cancer (mCRPC; a cancer of prostate, a male reproductive gland found below the
bladder, that grows despite low levels of male hormones).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Ronan FLIPPOT | 30/07/2026 15:05:33 | Contacter | ||
Critères
Tous
- 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:
- 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