phase 3 study of xaluritamig vs cabazitaxel or second androgen receptor-directed therapy in participants with progressive metastatic castration-resistant prostate cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the main objective of the study is to compare overall survival in participants receiving xaluritamig versus investigator's choice (cabazitaxel or second androgen receptor-directed therapy \[ardt\]).


Eligibility criteria:
inclusion criteria: * participant has provided informed consent prior to initiation of any study-specific activities/procedures. * age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * participant must have histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. * mcrpc with ≥ 1 metastatic lesion that is present on baseline computed tomography (ct), magnetic resonance imaging (mri), or bone scan imaging obtained within 28 days prior to enrollment. * evidence of progressive disease, defined as 1 or more pcwg3 criteria: * serum psa progression defined as 2 consecutive increases in psa over a previous reference value measured at least 1 week prior. the minimal start value is 2.0 ng/ml. * soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (sod) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sod since treatment started or the appearance of one or more new lesions. * progression of bone disease: evaluable disease or new bone lesion(s) by bone scan (2+2 pcwg3 criteria, scher et al, 2016). * participants must have had a prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (\< 50 ng/dl or \< 1.7 nmol/l). * prior treatment with at least one ardt. * prior treatment with one taxane therapy. prior treatment with docetaxel in the hormone-sensitive setting is permitted. participants who received two or more prior chemotherapy regimens in the castrate-resistant setting are not eligible. * prior treatment with radioligand therapy (rlt), radionuclide therapy (radium-223), poly adp-ribose polymerase (parp) inhibitor, or immune checkpoint inhibitor is permitted. * eastern cooperative oncology group performance status (ecog ps) of 0 or 1. * adequate organ function. key exclusion criteria: prior \& concomitant therapy: * prior six transmembrane epithelial antigen of the prostate 1 (steap1)-targeted therapy. * any anticancer therapy, immunotherapy, or investigational agent within 4 weeks prior to the first dose of study treatment, not including androgen suppression therapy. * prior prostate-specific membrane antigen (psma) radioligand therapy (rlt) within 2 months of the first dose of study treatment unless participants received \< 2 cycles of therapy. participants who received 1 cycle of psma rlt within 35 days prior to the first dose of study treatment are also excluded. * participants who started a bisphosphonate or denosumab regimen within 4 weeks prior to the first dose of study treatment. * radiation therapy within 4 weeks prior to the first dose of study treatment (or local or focal radiotherapy within 2 weeks prior to the first dose of study treatment). * concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, parp inhibitor, biological therapy, or investigational therapy. disease related: * participants with a history of central nervous system (cns) metastasis. * unresolved toxicities from prior anti-tumor therapy with ctcae version 5.0 events grade above 1 or baseline, with the exception of alopecia or toxicities that are stable and well controlled and there is an agreement to allow inclusion by both the investigator and the sponsor.

Keywords: oncology xaluritamig cabazitaxel prostate cancer abiraterone enzalutamide