A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The primary purpose of this study is to determine whether the investigational drug XmAb541 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 on tumor outcomes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:
• Age ≥ 18 years. For subjects with GCTs, age ≥15 years
• CLDN6+ tumor
• Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment
• Adequate Eastern Cooperative Oncology Group performance status
• Life expectancy ≥ 3 months
• Adequate liver, kidney, and bone marrow function
Locations
United States
California
City of Hope
NOT_YET_RECRUITING
Duarte
Stanford
NOT_YET_RECRUITING
Palo Alto
University of California
RECRUITING
San Francisco
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Indiana
Indian University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
New Jersey
The John Theruer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Montefiore Einstein Comprehensive Cancer Center
RECRUITING
The Bronx
Ohio
The Ohio State University
RECRUITING
Columbus
Oklahoma
OU Health Stephenson Cancer Center
RECRUITING
Oklahoma City
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Gabrielle Golden
info541-01@xencor.com
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 282
Treatments
Experimental: Dose escalation and Dose Expansion of XmAb541
Intravenous or Subcutaneous administration
Related Therapeutic Areas
Sponsors
Leads: Xencor, Inc.