Safe and tolerable dose test of XmAb541 plus XmAb808 in advanced ovarian cancer
Official title: A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors
Run by Xencor, Inc. · NCT07593092 · Data updated 2026-11-12
This study tests whether the drug combination XmAb541 and XmAb808 is safe and tolerable in adults with advanced ovarian cancer and looks at initial tumor responses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Xencor, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 4 sites (Lake Success, New York and 3 other locations) |
| Status | Recruiting |
| Started | June 30, 2026 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07593092 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 and older with CLDN6-positive, high-grade serous ovarian carcinoma (including fallopian tube or primary peritoneal origin) who are fit for investigational therapy and have adequate organ function.
✕Probably not a fit
Patients with non-CLDN6-positive tumors, significant autoimmune disease, or those who do not tolerate the combination may not benefit from this treatment approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional study evaluating the safety and tolerability of XmAb541 in combination with XmAb808 in participants with locally advanced, recurrent, or metastatic high-grade serous ovarian carcinoma. The trial aims to establish safe dosing regimens for the combination and to observe preliminary effects on tumor outcomes. Eligible patients have CLDN6-positive tumors and adequate organ function, with no recent systemic immunosuppression. Exclusion criteria include prior exposure to a CLDN6-targeting immune engager and active autoimmune disease. The study is sponsored by Xencor, Inc., with investigative sites in New York and The Bronx.
Why it matters
Potential benefit: If successful, participants may experience disease stabilization or tumor shrinkage with a tolerable safety profile and pave the way for future studies of this combination.
How similar studies have gone: Early-phase studies of similar antibody-based combinations in solid tumors have shown manageable safety and signals of activity, but this exact combination in HGSOC is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * CLDN6+ tumor * Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin * Adequate Eastern Cooperative Oncology Group performance status * Life expectancy ≥ 3 months * Adequate organ function Exclusion Criteria: * Prior exposure to a CLDN6 targeting immune cell engager * 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 viral hepatitis B or hepatitis C
Where it's running
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Xencor Investigative Site
Lake Success, New York, United States Recruiting -
Xencor Investigative Site
New York, New York, United States Recruiting -
Xencor Investigative Site
The Bronx, New York, United States Recruiting -
Xencor Investigative Site
Fort Worth, Texas, United States Recruiting
Study contacts
- Study coordinator: 541-02 Study Information
- Email: info541-02@xencor.com
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.