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

Purpose

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.

Conditions

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

Eligibility

Eligible Ages: Over 15 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Age ≥ 18 years. For 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 - 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

Prior exposure to a CLDN6 targeting product - 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)

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation and expansion study
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Dose escalation and Dose Expansion of XmAb541	Intravenous or Subcutaneous administration	Biological: XmAb541 Monoclonal bispecific antibody

Recruiting Locations

Winship Cancer Institute, Emory University
Atlanta, Georgia 30322

Karmanos Cancer Institute
Detroit, Michigan 48201

The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601

Montefiore Einstein Comprehensive Cancer Center
Bronx, New York 10461

Icahn School of Medicine at Mount Sinai
New York, New York 10029

The Ohio State University
Columbus, Ohio 43210

OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104

SCRI Oncology Partners
Nashville, Tennessee 37203

University of Virginia
Charlottesville, Virginia 22903

More Details

NCT ID: NCT06276491
Status: Recruiting
Sponsor: Xencor, Inc.

Study Contact

Mira Kistler, MD
mkistler@xencor.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.