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 |
|
Recruiting Locations
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Karmanos Cancer Institute
Detroit, Michigan 48201
Detroit, Michigan 48201
The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Montefiore Einstein Comprehensive Cancer Center
Bronx, New York 10461
Bronx, New York 10461
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
The Ohio State University
Columbus, Ohio 43210
Columbus, Ohio 43210
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
SCRI Oncology Partners
Nashville, Tennessee 37203
Nashville, Tennessee 37203
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
More Details
- NCT ID
- NCT06276491
- Status
- Recruiting
- Sponsor
- Xencor, Inc.