Actively Recruiting
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
Led by Xencor, Inc. · Updated on 2026-03-17
282
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and optimal dosing of an investigational drug called XmAb541 in people with advanced solid tumors, including ovarian cancer, endometrial cancer, and various germ cell tumors. This phase 1 study aims to understand how XmAb541 affects tumor outcomes while monitoring for side effects and adverse reactions. The study involves administering XmAb541 either intravenously or subcutaneously to participants. It includes a dose escalation phase to determine safe dose levels, followed by a dose expansion phase to further assess safety and tolerability. Participants receive the study drug and are monitored closely over time. Participants will undergo assessments for adverse events, dose-limiting toxicities, and cytokine release syndrome from the first dose up to two years. Researchers will also measure drug levels in the body, tumor response, duration of response, and changes in circulating tumor DNA. Safety and treatment effects are monitored regularly throughout the study period, which may last up to two years or more.
CONDITIONS
Brief Title
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older; for subjects with germ cell tumors, age 15 years or older
- CLDN6 positive tumor
- Documented locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer; adenocarcinoma of the endometrium; or germ cell tumor resistant to previous treatment
- Adequate Eastern Cooperative Oncology Group performance status
- Life expectancy of 3 months or more
- Adequate liver, kidney, and bone marrow function
You will not qualify if you...
- Active known or suspected autoimmune disease
- Requirement for 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 hepatitis B or hepatitis C
- Patients with treated brain metastases may participate only if radiologically stable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From Day 1 up to 2 years depending on individual treatment continuation
Participants receive XmAb541, a monoclonal bispecific antibody, through intravenous or subcutaneous administration to evaluate safety and tolerability.
Visits occur regularly during treatment for dosing and safety assessments
Trial Site Locations
Total: 16 locations
1
City of Hope
Duarte, California, United States, 91010
Not Yet Recruiting
2
Stanford
Palo Alto, California, United States, 94304
Not Yet Recruiting
3
University of California
San Francisco, California, United States, 94158
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Indian University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
9
The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
10
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
11
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, United States, 10461
Actively Recruiting
12
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
13
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
14
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
15
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
G
Gabrielle Golden
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here