Tests XmAb541 for safety in people with advanced solid tumors
Tests the new drug XmAb541 for safety and dosing in advanced ovarian and endometrial cancers.
Plain-language title generated from the registry record
Registry title: Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Key facts
- Where
- Herlev, DenmarkSee the site
- Phase
- Phase 1
Where in Denmark
- Herlev & Gentofte HospitalHerlev, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xencor, Inc.
- Trial code
- NCT06276491
- Record updated
- 9 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
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.
Inclusion: 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.
Exclusion: Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug; Active known or suspected autoimmune disease; Clinically significant cardiovascular, pulmonary or gastrointestinal disease; Active hepatitis B or hepatitis C; Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable.