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Recruiting

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

NCT06276491 · Xencor, Inc.
In plain English

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Official title
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
About this study
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
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
Study design
Enrollment target: 282 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2024-04-04
Estimated completion: 2028-12
Last updated: 2026-06-11
Interventions
Biological: XmAb541
Primary outcomes
  • Incidence of adverse events (Day 1 to 2 years)
  • Incidence of dose-limiting toxicities (DLTs) (Day 1 to Day 28)
  • Incidence of cytokine release syndrome (CRS) (Day 1 to Day 28)
Sponsor
Xencor, Inc. · industry
Contacts & investigators
ContactXmAb541-01 Central Contact · contact · info541-01@xencor.com
All locations (18)
City of HopeRecruiting
Duarte, California, United States
StanfordRecruiting
Palo Alto, California, United States
University of CaliforniaRecruiting
San Francisco, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Winship Cancer Institute, Emory UniversityRecruiting
Atlanta, Georgia, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterRecruiting
Indianapolis, Indiana, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
University of MinnesotaRecruiting
Minneapolis, Minnesota, United States
The John Theruer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Montefiore Einstein Comprehensive Cancer CenterRecruiting
The Bronx, New York, United States
The Ohio State UniversityRecruiting
Columbus, Ohio, United States
OU Health Stephenson Cancer CenterRecruiting
Oklahoma City, Oklahoma, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Herlev Gentofte HospitalNot Yet Recruiting
Herlev, Denmark
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors · TrialPath