RecruitingPhase 1NCT06276491

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

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

Sponsor

Xencor, Inc.

Enrollment

282 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Endometrial Cancer Germ Cell Tumor Ovarian Germ Cell Tumor Testicular Germ Cell Tumor

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

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing the safety of a new experimental drug called XmAb541 in patients with advanced cancers that express a protein called Claudin-6 (CLDN6). The drug is designed to specifically target cancer cells that have this protein on their surface. **You may be eligible if...** - You are 18 years or older (15 or older for germ cell tumors) - Your tumor tests positive for the CLDN6 protein - You have advanced ovarian, fallopian tube, peritoneal, endometrial, or uterine cancer, or a germ cell tumor that has not responded to prior treatment - Your general health and organ function are adequate - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have an active autoimmune disease - You have been taking corticosteroids or immune-suppressing drugs in the past 2 weeks - You have active hepatitis B or C - You have significant heart, lung, or digestive system problems - You have brain metastases that are not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALXmAb541

Monoclonal bispecific antibody

Locations(16)

City of Hope

Duarte, California, United States

Stanford

Palo Alto, California, United States

University of California

San Francisco, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Indian University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

The John Theruer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, United States

The Ohio State University

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06276491

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