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NCT06276491PHASE1Recruiting

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

Xencor, Inc.

Start Date

4/4/2024

Completion Date

12/1/2028

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 Criteria

Age Range: 15 years to No maximum

Key Inclusion Criteria: * Age ≥ 18 years. For US only: 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 Key Exclusion Criteria: * 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 hepatitis B or hepatitis C

Interventions

BIOLOGICAL

XmAb541

Interested in This Trial?

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Conditions

Ovarian CancerEndometrial CancerGerm Cell TumorTesticular Germ Cell TumorOvarian Germ Cell Tumor

Locations

City of Hope

Duarte, California 91010

United States

Stanford

Palo Alto, California 94304

United States

University of California

San Francisco, California 94158

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana 46202

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

The John Theruer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York 10461

United States

The Ohio State University

Columbus, Ohio 43210

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

SCRI Oncology Partners

Nashville, Tennessee 37203

United States

University of Virginia

Charlottesville, Virginia 22903

United States

Herlev Gentofte Hospital

Herlev, 2730

Denmark