Clinical trial • Phase I • Oncology
XmAb541 for Advanced solid tumors
Phase I trial of XmAb541 for Advanced solid tumors. 182 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced solid tumors
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 04-07-2025
- First CTIS Authorization Date
- 27-10-2025
Trial design
Phase I trial across 15 sites in Belgium, Denmark, France and others.
- Target Sample Size
- 182
Eligibility
Recruits 182 Vulnerable population selected; no details on consent or assent provided.
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided
Recruitment
- Planned Sample Size
- 182
- Recruitment Window Months
- 23
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 70
Belgium
- Earliest CTIS Part Ii Submission Date
- 29-09-2025
- Latest Decision Or Authorization Date
- 29-10-2025
- Processing Time Days
- 30
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- UZ Leuven
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- Toon Van Gorp
- Principal Investigator Email
- Toon.Vangorp@uzleuven.be
- Contact Person Name
- Toon Van Gorp
- Contact Person Email
- Toon.Vangorp@uzleuven.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Medical Oncology
- Principal Investigator Name
- Charles Pottier
- Principal Investigator Email
- Charles.Pottier@chuliege.be
- Contact Person Name
- Charles Pottier
- Contact Person Email
- Charles.Pottier@chuliege.be
- Site Name
- Institut Jules Bordet
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- Laetitia Collet
- Principal Investigator Email
- laetitia.collet@hubruxelles.be
- Contact Person Name
- Laetitia Collet
- Contact Person Email
- laetitia.collet@hubruxelles.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Medical Oncology
- Principal Investigator Name
- Philip R Debruyne
- Principal Investigator Email
- philip.debruyne@azgroeninge.be
- Contact Person Name
- Philip R Debruyne
- Contact Person Email
- philip.debruyne@azgroeninge.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 27-10-2025
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Rigshospitalet
- Department Name
- Clinical Oncology
- Principal Investigator Name
- Kristoffer Staal Rohrberg
- Principal Investigator Email
- kristoffer.staal.rohrberg@regionh.dk
- Contact Person Name
- Kristoffer Staal Rohrberg
- Contact Person Email
- kristoffer.staal.rohrberg@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- Trine Lembrecht Jorgensen
- Principal Investigator Email
- Trine.Joergensen@rsyd.dk
- Contact Person Name
- Trine Lembrecht Jorgensen
- Contact Person Email
- Trine.Joergensen@rsyd.dk
- Site Name
- Region Hovedstaden
- Department Name
- Oncology- Phase 1 Lead
- Principal Investigator Name
- Rikke Løvendahl Eefsen
- Principal Investigator Email
- rikke.helene.loevendahl.eefsen@regionh.dk
- Contact Person Name
- Rikke Løvendahl Eefsen
- Contact Person Email
- rikke.helene.loevendahl.eefsen@regionh.dk
France
- Earliest CTIS Part Ii Submission Date
- 24-09-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 40
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- Kaissa Ouali
- Principal Investigator Email
- kaissa.OUALI@gustaveroussey.fr
- Contact Person Name
- Kaissa Ouali
- Contact Person Email
- kaissa.OUALI@gustaveroussey.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Gynecologic Medical Oncology
- Principal Investigator Name
- Benoit You
- Principal Investigator Email
- benoit.you@laposte.net
- Contact Person Name
- Benoit You
- Contact Person Email
- benoit.you@laposte.net
- Site Name
- Institut Paoli Calmettes
- Department Name
- Oncology
- Principal Investigator Name
- Cecile Vicier
- Principal Investigator Email
- VICIERC@ipc.unicancer.fr
- Contact Person Name
- Cecile Vicier
- Contact Person Email
- VICIERC@ipc.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 30-10-2025
- Processing Time Days
- 45
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Quironsalud Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Guzman Alonso Casal
- Principal Investigator Email
- galonso@nextoncology.eu
- Contact Person Name
- Guzman Alonso Casal
- Contact Person Email
- galonso@nextoncology.eu
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Gynecologic Oncology
- Principal Investigator Name
- Valentina Boni
- Principal Investigator Email
- vboni@nextoncology.eu
- Contact Person Name
- Valentina Boni
- Contact Person Email
- vboni@nextoncology.eu
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Gastrointestinal Oncology-Phase 1 Unit
- Principal Investigator Name
- Ignacio Matos García
- Principal Investigator Email
- imatos@unav.es
- Contact Person Name
- Ignacio Matos García
- Contact Person Email
- imatos@unav.es
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- Medical Oncology- Phase 1 Clinical Trials Unit
- Principal Investigator Name
- Alberto Hernando Calvo
- Principal Investigator Email
- albertohernando@vhio.net
- Contact Person Name
- Alberto Hernando Calvo
- Contact Person Email
- albertohernando@vhio.net
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Gastrointestinal Oncology-Phase 1 Unit
- Principal Investigator Name
- Ignacio Matos García
- Principal Investigator Email
- imatos@unav.es
- Contact Person Name
- Ignacio Matos García
- Contact Person Email
- imatos@unav.es
Sponsor
Primary sponsor
- Full Name
- Xencor Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- XmAb541
Related trials
Other published trials that may interest you.