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

Purpose

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.

Condition

  • Ovarian Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation and Dose Expansion of XmAb541 and XmAb808
  • Biological: XmAb541
    Monoclonal Bispecific Antibody
  • Biological: XmAb808
    Monoclonal Bispecific Antibody

Recruiting Locations

Xencor Investigative Site
Lake Success, New York 11042

Xencor Investigative Site
New York, New York 10029

Xencor Investigative Site
The Bronx, New York 10461

Xencor Investigative Site
Fort Worth, Texas 76104

More Details

Status
Recruiting
Sponsor
Xencor, Inc.

Study Contact

541-02 Study Information
info541-02@xencor.com