A Study Testing the Investigational Drug XmAb541 in people with Advanced Cancer

Status Authorised, recruitment pending · 4 EU/EEA countries · 15 sites · Protocol XmAb541-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 252

Countries 4

Sites 15

Advanced Solid Tumors

Key facts

Sponsor: Xencor Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Decision date (initial): 2025-10-29
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2025-521981-90-00
ClinicalTrials.gov: NCT06276491

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Advanced Solid Tumors

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Xencor Inc.

Sponsor organisation: Xencor Inc.
Address: 465 North Halstead Street Suite 200
City: Pasadena
Postcode: 91107-3291
Country: United States

Scientific contact point

Organisation: Xencor Inc.
Contact name: Dr. Mira Kistler

Public contact point

Organisation: Xencor Inc.
Contact name: Gabrielle Golden

Locations

4 EU/EEA countries · 15 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Authorised, recruitment pending	20	4
Denmark	Authorised, recruitment pending	15	3
France	Authorised, recruitment pending	15	3
Spain	Authorised, recruitment pending	20	5
Rest of world United Kingdom, United States	—	182	—

Investigational sites

Belgium

4 sites · Authorised, recruitment pending

UZ Leuven

Gynecologic Oncology, Herestraat 49, 3000, Leuven

Centre hospitalier universitaire de Liege

Medical Oncology, Avenue De L'Hopital 1, 4000, Liege

Institut Jules Bordet

Gynecologic Oncology, Mijlenmeersstraat 90, 1070, Anderlecht

Algemeen Ziekenhuis Groeninge

Medical Oncology, President Kennedylaan 4, 8500, Kortrijk

Denmark

3 sites · Authorised, recruitment pending

Rigshospitalet

Clinical Oncology, Blegdamsvej 9, 2100, Copenhagen Oe

Odense University Hospital

Gynecologic Oncology, J. B. Winsloews Vej 4, 5000, Odense C

Region Hovedstaden

Oncology- Phase 1 Lead, Borgmester Ib Juuls Vej 1, 2730, Herlev

France

3 sites · Authorised, recruitment pending

Institut Gustave Roussy

Gynecologic Oncology, 114 Rue Edouard Vaillant, 94800, Villejuif

Hospices Civils De Lyon

Gynecologic Medical Oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite

Institut Paoli Calmettes

Oncology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille

Spain

5 sites · Authorised, recruitment pending

Hospital Quironsalud Barcelona

Medical Oncology, Placa D'alfonso Comin 5-7, 08023, Barcelona

Hospital Universitario Quironsalud Madrid

Gynecologic Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon

Clinica Universidad De Navarra

Gastrointestinal Oncology-Phase 1 Unit, Calle Marquesado De Santa Marta 1, 28027, Madrid

Vall D Hebron Institute Of Oncology

Medical Oncology- Phase 1 Clinical Trials Unit, Calle Natzaret 115, 08035, Barcelona