Ireland
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Recruiting Phase 1

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

NCT06276491 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-04-04
Last updated
2026-10-09

Condition(s) studied

Ovarian CancerEndometrial CancerGerm Cell TumorTesticular Germ Cell TumorOvarian Germ Cell Tumor

Investigational drug(s) / intervention(s)

XmAb541 →

XmAb541: Monoclonal bispecific antibody

Study 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

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
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: * Participants with untreated brain metastases are excluded. Participants 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

Primary outcome measure(s)

  • 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

Trial sites (27)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Stanford University Palo Alto California Recruiting
University of California San Francisco San Francisco California Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
The John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey Recruiting
Icahn School of Medicine at Mount Sinai New York New York Recruiting
Montefiore Einstein Comprehensive Cancer Center The Bronx New York Recruiting
The Ohio State University Columbus Ohio Recruiting
OU Health Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
University of Virginia Charlottesville Virginia Recruiting
AZ Groeninge Kortrijk Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
CHU de Liege Liège Belgium Recruiting
Herlev Gentofte Hospital Herlev Denmark Recruiting
Centre Hospitalier Lyon-Sud Pierre-Bénite France Recruiting
NEXT Oncology - Hospital Quironsalud Barcelona Spain Recruiting
Clinical Universidad de Navarra Madrid Spain Recruiting
NEXT Oncology - Hospital Quironsalud Madrid Spain Recruiting
Clinical Universidad de Navarra Pamplona Spain Recruiting
The Christie NHS Foundation Trust Manchester United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06276491 on ClinicalTrials.gov ↗ ← All trials in the USA