Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
NCT ID: NCT06276491
Last Updated: 2025-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
212 participants
INTERVENTIONAL
2024-04-04
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation and Dose Expansion of XmAb541
Intravenous or Subcutaneous administration
XmAb541
Monoclonal bispecific antibody
Interventions
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XmAb541
Monoclonal bispecific antibody
Eligibility Criteria
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Inclusion Criteria
* 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
* Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.
* Eastern Cooperative Oncology Group performance status of 0-2
* Life expectancy ≥ 3 months
* Adequate liver, kidney, and bone marrow function
Exclusion Criteria
* Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
* Have known active central nervous system metastases and/or carcinomatous meningitis. 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
* Positive test for hepatitis C RNA
* Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)
15 Years
ALL
No
Sponsors
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Xencor, Inc.
INDUSTRY
Responsible Party
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Locations
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Winship Cancer Institute, Emory University
Atlanta, Georgia, 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
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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XmAb541-01
Identifier Type: -
Identifier Source: org_study_id
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