NCT06276491RecruitingPhase 1
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 282 (estimated)
- First submitted
- 16 Feb 2024
- Start date
- 4 Apr 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Xencor, Inc.
- NCT number
- NCT06276491
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 282
- From 4 Apr 2024 to the primary completion date, Dec 2027
- 27 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
Other illness
- Active known or suspected autoimmune disease
- Clinically significant cardiovascular, pulmonary or gastrointestinal disease
- Active hepatitis B or hepatitis C
Other
- Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable.
Who the study is looking for
- Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years
- CLDN6+ tumor
- Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment
- Adequate Eastern Cooperative Oncology Group performance status
- Life expectancy ≥ 3 months
- Adequate liver, kidney, and bone marrow function
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Herlev & Gentofte Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| NEXT Oncology - Hospital Quironsalud Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Clinical Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| NEXT Oncology Hospital Quironsalud Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clinical Universidad de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| The Christie NHS Foundation Trust Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Winship Cancer Institute, Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| The John Theurer Cancer Center at Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| OU Health Stephenson Cancer Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Montefiore Einstein Comprehensive Cancer Center Coordinator of this site? Confirm its status | The Bronx | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.