Recruiting
Phase 1

XmAb541 & XmAb808

Sponsor:

Xencor, Inc.

Code:

NCT07593092

Conditions

Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XmAb541

XmAb808

Study Details

Brief 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.

Conditions

Ovarian Cancer

Study ID

NCT07593092

Start date

Jun 30, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation and Dose Expansion of XmAb541 and XmAb808

Interventions

XmAb541

Monoclonal Bispecific Antibody

XmAb808

Monoclonal Bispecific Antibody

Primary outcome measure

  • Incidence of Adverse Events [ Time Frame: Day 1 to 2 years ]
  • Incidence of dose-limiting toxicities [ Time Frame: Day 1 to Day 43 ]

Central Contacts and Locations

Central contacts

541-02 Study Information

info541-02@xencor.com

Locations

Xencor Investigative Site

Recruiting

Lake Success, New York, United States, 11042

Xencor Investigative Site

Recruiting

New York, New York, United States, 10029

Xencor Investigative Site

Recruiting

The Bronx, New York, United States, 10461

Xencor Investigative Site

Recruiting

Fort Worth, Texas, United States, 76104

More Information

Sponsor

Xencor, Inc.

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Phase 1
  • Ovarian Cancer
  • HGSOC
  • B7H3
  • CLDN6
  • T-cell Engager

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Xencor, Inc. on 2026-08-13.