Trials Today

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 Sex: 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 4180439, Georgia 4197000 30322

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201

The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

Montefiore Einstein Comprehensive Cancer Center
The Bronx 5110266, New York 5128638 10461

The Ohio State University
Columbus 4509177, Ohio 5165418 43210

OU Health Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203

University of Virginia
Charlottesville 4752031, Virginia 6254928 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.