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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of Adverse Events — Day 1 to 2 years
Incidence of dose-limiting toxicities — Day 1 to Day 43
Trial sites (4)
Facility
City
Region
Status
Xencor Investigative Site
Lake Success
New York
Recruiting
Xencor Investigative Site
New York
New York
Recruiting
Xencor Investigative Site
The Bronx
New York
Recruiting
Xencor Investigative Site
Fort Worth
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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