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NCT07593092PHASE1Recruiting

Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors

Xencor, Inc.

Start Date

6/30/2026

Completion Date

12/1/2028

Summary

The primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug XmAb808 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 in combination with XmAb808 on participants' tumor outcomes.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

XmAb541

BIOLOGICAL

XmAb808

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Conditions

Ovarian Cancer

Locations

Xencor Investigative Site

Lake Success, New York 11042

United States

Xencor Investigative Site

New York, New York 10029

United States

Xencor Investigative Site

The Bronx, New York 10461

United States

Xencor Investigative Site

Fort Worth, Texas 76104

United States