Trial: Phase 3 Study of Xaluritamig vs Cabazit…

Trial Details

Sponsor: Amgen (industry)

Phase: 3

Start date: Dec. 9, 2024

Planned enrollment: 675

Trial ID: NCT06691984

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Xaluritamig (AMG 509)

Overview

Xaluritamig (AMG 509) is an investigational, first‑in‑class bispecific T‑cell–engaging antibody being developed for prostate cancer. It targets the prostate cancer antigen STEAP1 and CD3 on T cells. Initial human data in metastatic castration‑resistant prostate cancer (mCRPC) show antitumor activity with a safety profile characterized by mostly early, manageable cytokine release syndrome (CRS). A global phase 1 program is ongoing across late‑ and earlier‑stage settings, and Amgen has initiated/enrolled additional phase 1b studies and a phase 3 trial in post‑taxane mCRPC. (aacrjournals.org, ichgcp.net, cdek.pharmacy.purdue.edu, amgen.com)

Mechanism of action

Bispecific XmAb “2+1” format with two STEAP1‑binding Fabs to increase target avidity and one anti‑CD3 scFv to recruit and activate T cells against STEAP1‑expressing tumor cells; engineered Fc reduces effector function and extends half‑life. STEAP1 is highly overexpressed in prostate cancer and largely absent/low in normal tissues. (aacrjournals.org)
STEAP1 overexpression in prostate tumors and its association with more aggressive disease have been documented in translational and pathology studies. (pubmed.ncbi.nlm.nih.gov, ncbi.nlm.nih.gov)

Efficacy

First‑in‑human, phase 1 (NCT04221542) monotherapy dose‑exploration/optimization in heavily pretreated mCRPC: - Across all dose cohorts (n≈97): confirmed PSA50 response in 49% and RECIST v1.1 objective response rate (ORR) 24% among patients with measurable disease. (aacrjournals.org, pubmed.ncbi.nlm.nih.gov) - At target doses ≥0.75 mg: PSA50 59% and ORR 41%. (aacrjournals.org)

Longer follow‑up and dose‑optimization (ESMO 2024 and company summary): - In dose‑exploration cohorts, median overall survival (OS) ~17–18 months with longer follow‑up; higher‑depth PSA90 response correlated with improved survival. (oncologypro.esmo.org, nasdaq.com) - In a randomized dose‑expansion comparing target doses (0.75 mg vs 1.5 mg), the 1.5 mg regimen improved efficacy and was selected for further development (recommended for phase 3). (oncologypro.esmo.org, nasdaq.com)

Safety

Most common treatment‑related adverse events in phase 1 were CRS (any grade 72%), fatigue (45%), and myalgia (34%). CRS occurred primarily during cycle 1 and was mitigated by premedication and step‑up dosing. The maximum tolerated dose identified in weekly step‑up was 1.5 mg. (aacrjournals.org, pubmed.ncbi.nlm.nih.gov)
With dose optimization, grade 3 events were described as mostly transient and manageable, allowing treatment continuation in most patients; the 1.5 mg target regimen (every 2 weeks in optimization) was judged to have a favorable efficacy/safety profile for phase 3. (oncologypro.esmo.org, nasdaq.com)

Development status and ongoing studies

Phase 1, multi‑part study in mCRPC (NCT04221542) including monotherapy and combinations with abiraterone or enzalutamide; parts exploring reduced monitoring and outpatient administration are ongoing. Primary completion is estimated for February 2026. (ichgcp.net)
Neoadjuvant phase 1b study in localized intermediate/high‑risk prostate cancer (trial TPS434; NCT06613100) is enrolling. (ascopubs.org, clinicaltrials.ucsf.edu)
A phase 3 study in post‑taxane mCRPC has been initiated/enrolling. (amgen.com)

HealthScout AI Analysis

Goal: Compare overall survival of xaluritamig versus investigator’s choice of cabazitaxel or a second androgen receptor–directed therapy (abiraterone or enzalutamide) in post-taxane metastatic castration-resistant prostate cancer (mCRPC).

Patients: Adults with histologically confirmed prostate adenocarcinoma and mCRPC, at least one measurable or bone lesion, evidence of progression per PCWG3 criteria, castrate testosterone levels while on continuous ADT or after orchiectomy, prior progression on at least one AR-directed therapy, and exactly one prior taxane in the mCRPC setting (docetaxel in mHSPC allowed in addition). ECOG 0–1 and adequate organ function required. Key exclusions include prior STEAP1-targeted therapy, recent anticancer therapy, recent PSMA-RLT (unless <2 cycles), recent radionuclide or palliative radiotherapy without recovery, active concurrent systemic anticancer therapies, and history of CNS metastases other than treated, asymptomatic, stable dural disease.

Design: Phase 3, open-label, multicenter, randomized trial with approximately 675 participants allocated to xaluritamig versus investigator’s choice of cabazitaxel or second AR-directed therapy. Primary purpose is treatment; analyses will compare survival and key efficacy and patient-reported endpoints between arms with blinded independent central review for radiographic endpoints.

Treatments: Xaluritamig (AMG 509) administered by intravenous infusion. Xaluritamig is an investigational, first-in-class bispecific T-cell–engaging antibody targeting STEAP1 on prostate cancer cells and CD3 on T cells, using an XmAb 2+1 format to enhance STEAP1 avidity with a reduced-effector Fc. In phase 1 mCRPC studies, xaluritamig demonstrated antitumor activity (approximate PSA50 49% overall; higher responses at target doses) with a safety profile notable for mostly early, manageable cytokine release syndrome mitigated by step-up dosing and premedication; a 1.5 mg target regimen was selected for further development. Comparator arm: cabazitaxel IV or a second AR-directed therapy (abiraterone or enzalutamide) given per standard dosing at investigator discretion.

Outcomes: Primary endpoint is overall survival. Key secondary endpoints include rPFS by PCWG3-modified RECIST v1.1 per blinded independent central review, objective response rate, duration of response, disease control rate, time to response, time to first symptomatic skeletal event, safety and tolerability (TEAEs), patient-reported outcomes (BPI-SF pain measures, FACT-P, EQ-5D-5L, PRO-CTCAE), PSA50 and PSA90 response rates, and pharmacokinetics and immunogenicity of xaluritamig (Cmax, Tmax, Cmin, AUC, accumulation, half-life, anti-drug antibodies). Assessments are planned for up to approximately 43 months.

Burden on patient: Moderate. Participants will require regular clinic visits for IV administration, especially early cycle monitoring for cytokine release syndrome with potential step-up dosing and premedications. Imaging for rPFS with BICR, serial PSA testing, frequent safety labs, and comprehensive PRO questionnaires add to visit time but are consistent with advanced mCRPC trials. The xaluritamig arm may include additional pharmacokinetic and immunogenicity blood draws, particularly in early cycles, increasing chair time and venipuncture frequency. Oral comparator options may lessen visit burden, whereas cabazitaxel involves infusion visits similar to xaluritamig. Travel demands are typical for phase 3 oncology studies, without mandated biopsies or highly intensive procedures reported.

Eligibility

Show 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. Mixed histologies (eg, adenocarcinoma with neuroendocrine component) are not permitted.

* 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 or unequivocal progression of existing non-target lesions.

* Progression of bone disease: defined by the appearance of at least 2 new bone lesion(s) by bone scan (as per the 2+2 PCWG3 criteria).

* 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 progression on at least one ARDT (enzalutamide, abiraterone, apalutamide, darolutamide).

* Prior treatment with only one taxane therapy in the mCRPC setting. Note: Prior treatment with docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting is permitted; however, participants must have also received one, and only one, taxane therapy in the mCRPC setting.

* 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 (eg, luteinizing hormone-releasing hormone/gonadotropin-releasing hormone \[LHRH/GnRH\] analogue \[agonist/antagonist\]).

* Prior Prostate-Specific Membrane Antigen (PSMA) radioligand therapy (RLT) within 3 months of the first dose of study treatment unless participants received \< 2 cycles of therapy.

* Prior palliative radiotherapy within 2 weeks of first dose of study treatment. Participants must have recovered from all radiation-related toxicities.

* Concurrent cytotoxic chemotherapy, ARDT, immunotherapy, radioligand therapy, PARP inhibitor, biological therapy, investigational therapy. Note: Prior treatment with a PARP inhibitor is permitted as long as not within 4 weeks before first dose of study treatment.

* Prior radionuclide therapy (Radium-223) within 2 months of first dose of study treatment.

* Treatment with live and live-attenuated vaccines within 4 weeks before the first dose of study treatment.

Disease Related:

* Participants with a history of central nervous system (CNS) metastasis. Note: Participants with treated, asymptomatic, and clinically stable dural metastases are eligible.

* Unresolved toxicities from prior anti-tumor therapy not having resolved to 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.

Sites (122)

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Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

No email / No phone

Status: Recruiting

Macquarie University

North Ryde, New South Wales, 2109, Australia

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Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

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Monash Medical Centre

Clayton, Victoria, 3168, Australia

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The Alfred Hospital

Melbourne, Victoria, 3004, Australia

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Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

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Ordensklinikum Linz Elisabethinen

Linz, 4020, Austria

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Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

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Krankenhaus der Barmherzigen Brueder Wien

Vienna, 1020, Austria

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Universitaetsklinikum Sankt Poelten

Sankt Pölten, 3100, Austria

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Landeskrankenhaus Salzburg

Salzburg, 5020, Austria

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Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, 4000, Belgium

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Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Kortrijk, 8500, Belgium

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Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

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Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

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BC Cancer Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

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Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z5, Canada

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CHU de Quebec-Universite Laval

Québec, Quebec, G1R 2J6, Canada

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Sir Mortimer B Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

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Vejle Sygehus

Vejle, 7100, Denmark

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Aarhus University Hospital

Aarhus N, 8200, Denmark

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Gustave Roussy

Villejuif, 94805, France

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Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

La Tronche, 38700, France

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Clinique Victor Hugo - Centre Jean Bernard

Le Mans, 72000, France

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Centre Antoine Lacassagne

Nice, 06189, France

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Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059, France

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Universitaetsklinikum Schleswig-Holstein - Luebeck

Lübeck, 23538, Germany

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Universitaetsklinikum Jena

Jena, 07747, Germany

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Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

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Universitaetsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

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Universitaetsklinikum Essen

Essen, 45147, Germany

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Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

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Universitaetsklinikum Muenster

Münster, 48149, Germany

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Klinikum rechts der Isar der TUM

München, 81675, Germany

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Universitaetsklinikum Dresden

Dresden, 01307, Germany

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Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

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Athens Medical Center S.A - Iatriko Amarousiou

Athens, 15125, Greece

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Metropolitan General

Athens, 15562, Greece

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Metropolitan Hospital

Athens, 18547, Greece

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Saint Luke Hospital

Thessaloniki, 55236, Greece

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European Interbalkan Medical Center

Thessaloniki, 57001, Greece

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Alexandra Hospital

Athens, 11528, Greece

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Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

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Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, 71122, Italy

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Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

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Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce

Gallipoli, 73014, Italy

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Ospedale Santa Chiara "Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento"

Trento, 38122, Italy

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

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IRCCS Ospedale San Raffaele

Milan, 20132, Italy

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Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

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National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

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National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

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Kanazawa University Hospital

Kanazawa, Ishikawa-ken, 920-8641, Japan

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Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

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Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

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The University of Osaka Hospital

Suita-shi, Osaka, 565-0871, Japan

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The Cancer institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, 135-8550, Japan

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Nippon Medical School Hospital

Bunkyo-ku, Tokyo, 113-8603, Japan

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Reinier de Graaf Gasthuis

Delft, 2625 AD, Netherlands

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Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

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Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

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SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

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National University Hospital

Singapore, 119074, Singapore

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Tan Tock Seng Hospital

Singapore, 308433, Singapore

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National Cancer Centre Singapore

Singapore, 168583, Singapore

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Chungnam National University Hospital

Daejeon, 35015, South Korea

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National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

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Seoul National University Hospital

Seoul, 03080, South Korea

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Severance Hospital Yonsei University Health System

Seoul, 03722, South Korea

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Asan Medical Center

Seoul, 05505, South Korea

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Hospital Regional Universitario de Malaga

Málaga, Andalusia, 29011, Spain

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Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

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Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

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Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

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Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

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Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

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Instituto Valenciano de Oncologia

Castellon, Valencia, 12002, Spain

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Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

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Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

Barcelona, 08908, Spain

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Hospital Clinico San Carlos

Madrid, 28040, Spain

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Skanes Universitetssjukhus

Lund, 221 85, Sweden

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Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

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Norrlands Universitetssjukhus

Umeå, 901 85, Sweden

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Karolinska Universitetssjukhuset

Stockholm, 171 76, Sweden

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Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

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Inselspital Bern

Bern, 3010, Switzerland

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Kantonsspital Graubuenden

Chur, 7000, Switzerland

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Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

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Kantonsspital Sankt Gallen

Sankt Gallen, 9007, Switzerland

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756, Taiwan

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Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan District, 33305, Taiwan

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National Taiwan University Hospital

Taipei, 10002, Taiwan

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National Cheng Kung University Hospital

Tainan City, 70403, Taiwan

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Taichung Veterans General Hospital

Taichung, 40705, Taiwan

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Izmir Medical Point Hastanesi

Izmir, 35575, Turkey (Türkiye)

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University College London Hospital

London, NW1 2PG, United Kingdom

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Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

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Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

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Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

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Guys Hospital

London, SE1 9RY, United Kingdom

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City of Hope National Medical Center

Duarte, California, 91010, United States

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University of California Irvine

Irvine, California, 92697, United States

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Providence Saint Jude Medical Center

Fullerton, California, 92835, United States

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AdventHealth Orlando

Orlando, Florida, 32804, United States

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Norton Cancer Institute

Louisville, Kentucky, 40207, United States

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Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

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Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

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University of Minnesota

Minneapolis, Minnesota, 55455, United States

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Washington University

St Louis, Missouri, 63110, United States

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Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States

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Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

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Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, 57104, United States

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Tennessee Oncology PLLC

Nashville, Tennessee, 37203, United States

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Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

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University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

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Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

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Status: Recruiting

Swedish Medical Center

Seattle, Washington, 98104, United States

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Status: Recruiting

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53705, United States

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Status: Recruiting

A Phase 3, Open-label, Multicenter, Randomized Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Subjects With Metastatic Castration-Resistant Prostate Cancer Previously Treated With Chemotherapy

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: Xaluritamig (AMG 509)

Overview

Mechanism of action

Efficacy

Safety

Development status and ongoing studies

Further reading

HealthScout AI Analysis

Eligibility

Show Criteria

Sites (122)

Chris OBrien Lifehouse

Macquarie University

Princess Alexandra Hospital

Monash Medical Centre

The Alfred Hospital

Fiona Stanley Hospital

Ordensklinikum Linz Elisabethinen

Universitaetsklinikum Allgemeines Krankenhaus Wien

Krankenhaus der Barmherzigen Brueder Wien

Universitaetsklinikum Sankt Poelten

Landeskrankenhaus Salzburg

Centre Hospitalier Universitaire de Liege - Sart Tilman

Algemeen Ziekenhuis Groeninge - Campus Kennedylaan

Universitair Ziekenhuis Gent

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

BC Cancer Vancouver

Princess Margaret Cancer Centre

CHU de Quebec-Universite Laval

Sir Mortimer B Davis - Jewish General Hospital

Vejle Sygehus

Aarhus University Hospital

Gustave Roussy

Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

Clinique Victor Hugo - Centre Jean Bernard

Centre Antoine Lacassagne

Institut Universitaire du Cancer Toulouse Oncopole

Universitaetsklinikum Schleswig-Holstein - Luebeck

Universitaetsklinikum Jena

Universitaetsklinikum Heidelberg

Universitaetsklinikum Hamburg Eppendorf

Universitaetsklinikum Essen

Universitaetsklinikum Wuerzburg

Universitaetsklinikum Muenster

Klinikum rechts der Isar der TUM

Universitaetsklinikum Dresden

Charite - Universitaetsmedizin Berlin, Campus Mitte

Athens Medical Center S.A - Iatriko Amarousiou

Metropolitan General

Metropolitan Hospital

Saint Luke Hospital

European Interbalkan Medical Center

Alexandra Hospital

Queen Mary Hospital, The University of Hong Kong

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Ospedale Policlinico San Martino IRCCS

Ospedale Sacro Cuore di Gesù Azienda Sanitaria Locale di Lecce

Ospedale Santa Chiara "Azienda Provinciale per i Servizi Sanitari Provincia Autonoma di Trento"

Fondazione IRCCS Istituto Nazionale dei Tumori

IRCCS Ospedale San Raffaele

Nagoya University Hospital

National Hospital Organization Shikoku Cancer Center

National Hospital Organization Hokkaido Cancer Center

Kanazawa University Hospital

Yokohama City University Medical Center

Osaka International Cancer Institute

The University of Osaka Hospital

The Cancer institute Hospital of Japanese Foundation for Cancer Research

Nippon Medical School Hospital

Reinier de Graaf Gasthuis

Radboud Universitair Medisch Centrum

Universitair Medisch Centrum Groningen

SPZOZ Szpital Uniwersytecki w Krakowie

National University Hospital

Tan Tock Seng Hospital

National Cancer Centre Singapore