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.
The primary objective is to determine whether treatment with pasritamig+docetaxel prolongs rPFS compared with docetaxel in participants with mCRPC who have progressed on at least one ARPI. rPFS is defined as the time from randomization to the time of BICR-assessed radiographic progression by CT/MRI or bone scan per PCWG3 and RECIST v1.1, or death from any cause, whichever occurs first.
The key secondary objective isto demonstrate additional clinical benefit for participants with mCRPC who have progressed on at least one ARPI treated with pasritamig+docetaxel compared with docetaxel. Clinical benefit will be assessed by OS, time to symptomatic progression, time to subsequent therapy, and time to skeletal-related event.
Pasritamig (JNJ-78278343)
- Rutgers University
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: - 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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