RecruitingPhase 3

A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether xaluritamig plus abiraterone helps people live longer than a doctor's choice of docetaxel, cabazitaxel, or abiraterone. It is for adults with prostate cancer that has spread and keeps growing despite very low testosterone levels. They must not have had chemotherapy for this stage of their cancer.

The primary objective of this study is to compare overall survival (OS) in participants receiving xaluritamig plus abiraterone against investigator's choice (docetaxel, cabazitaxel, or abiraterone).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give informed consent before any study procedures and be at least 18, or the legal adult age in your country if older.
  • Have prostate adenocarcinoma, a cancer that starts in gland cells, confirmed by testing. Mixed cancer types are not allowed.
  • Have cancer that has spread and grows despite very low testosterone. A CT, MRI, or bone scan within 28 days before joining must show at least one spot where it has spread.
  • Have signs that cancer is getting worse, such as rising PSA blood levels, growing tumors, or new cancer spots, that meet the study's rules.
  • Have had surgery to remove the testicles, be taking testosterone-lowering treatment, or both. Testosterone must be below 50 ng/dL.
  • Have cancer that got worse after exactly one of these hormone-blocking drugs: enzalutamide, apalutamide, or darolutamide.
  • If cabazitaxel is planned, have previously received docetaxel for cancer that had spread but still responded to hormone treatment, with no more than 6 cycles.
  • Be fully active or able to do light work despite limits on hard physical activity. Organs must work well enough for the study.

Who can't join

  • Have ever had cancer spread to the brain or spinal cord.
  • Still have more than mild side effects from earlier cancer treatment. Hair loss or stable, well-controlled effects may be allowed with approval.
  • Have had STEAP1-targeted or CD3-directed treatment, which targets specific proteins, or had cancer worsen on abiraterone or could not tolerate it.
  • Have had chemotherapy for cancer that grows despite very low testosterone, or more than 6 docetaxel cycles when the cancer still responded to hormone treatment.
  • Have had cancer treatment, immune treatment, or an experimental drug within 4 weeks before study treatment. Enzalutamide, darolutamide, and apalutamide need a 2-week break; testosterone-lowering treatment is allowed.
  • Have had targeted radioactive treatment within 8 weeks, radium-223 within 2 months, or radiation for symptom relief within 2 weeks before study treatment. Radiation side effects must have cleared.
  • Are also receiving chemotherapy, hormone-pathway blockers, immune treatment, targeted radioactive treatment, PARP inhibitors, biological treatment, or experimental treatment.
  • Have received a live or weakened-live vaccine within 4 weeks before study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Participant has provided informed consent before 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. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted. * Metastatic castration-resistant prostate cancer (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 before enrollment. * Evidence of progressive disease (PD), defined as 1 or more PCWG3-modified RECIST 1.1 criteria: * Serum PSA progression is defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimum 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 1 or more new lesions or unequivocal progression of existing non-target lesions. * Progression of bone disease defined by the appearance of at least 2 new bone lesions(s) by bone scan (as per the 2+2 PCWG3-modified RECIST 1.1 criteria). * Participants must have had prior orchiectomy and/or ongoing androgen-deprivation therapy (ADT) and a castrate level of serum testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior disease progression on 1, and only 1, androgen receptor pathway inhibitor (ARPI) (either enzalutamide, apalutamide, or darolutamide) is required. * Participants intended to receive cabazitaxel must have previously received ≤ 6 cycles of docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Adequate organ function. Exclusion Criteria: Disease Related: * Participants with a history of central nervous system (CNS) metastases. * Unresolved toxicities from prior antitumor therapy not having resolved to CTCAE version 5.0 grade 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. Prior/Concomitant Therapy: * Prior six transmembrane epithelial antigen of the prostate 1 (STEAP1)-targeted therapy. * Prior disease progression on or intolerance to abiraterone. * Prior treatment with any chemotherapy regimen in the mCRPC setting and/or \> 6 cycles of docetaxel treatment in the mHSPC setting. * Any anticancer therapy, immunotherapy, or investigational agent within 4 weeks before first dose of study treatment with the following exceptions: * Androgen receptor pathway inhibitors (ARPIs; enzalutamide, darolutamide, apalutamide): minimum washout of 2 weeks prior to the first dose of study treatment. * Androgen suppression therapy (eg, luteinizing hormone-releasing hormone/gonadotrophin releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]) is permitted. * Prior radioligand therapy (RLT) within 8 weeks of first dose of study treatment. * Prior radionuclide therapy (radium-223) within 2 months of first dose of study treatment. * Prior palliative radiotherapy within 2 weeks before first dose of study treatment. Participants must have recovered from all radiation-related toxicities. * Concurrent cytotoxic chemotherapy, ARPI, immunotherapy, RLT, poly adenosine diphosphate ribose polymerase (PARP) inhibitor, biological therapy, investigational therapy. * Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment. * Prior CD3-directed therapy.

Study sites (45)

AZ

CA

CO

CT

DE

  • Medical Oncology Hematology Consultants Helen F Graham Cancer Center · Newark, DE 19713More trials in Newark

FL

GA

IL

KS

KY

MD

MI

MN

NY

OH

OK

OR

PA

SC

TN

TX

VA

WA