NCT06276491 Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
| NCT ID | NCT06276491 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Xencor, Inc. |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 282 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 282 participants in total. It began in 2024-04-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Key Inclusion Criteria: * Age ≥ 18 years. For 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 Key Exclusion Criteria: * Patients with treated brain metastases may participate, provided they are radiologically stable. * Active known or suspected autoimmune disease * Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug * Clinically significant cardiovascular, pulmonary or gastrointestinal disease * Active hepatitis B or hepatitis C
Contact & Investigator
Gabrielle Golden
✉ info541-01@xencor.comFrequently Asked Questions
Who can join the NCT06276491 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06276491 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06276491 currently recruiting?
Yes, NCT06276491 is actively recruiting participants. Contact the research team at info541-01@xencor.com for enrollment information.
Where is the NCT06276491 trial being conducted?
This trial is being conducted at Duarte, United States, Palo Alto, United States, San Francisco, United States, Tampa, United States and 11 additional locations.
Who is sponsoring the NCT06276491 clinical trial?
NCT06276491 is sponsored by Xencor, Inc.. The trial plans to enroll 282 participants.
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