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 |
|
Recruiting Locations
Winship Cancer Institute, Emory University
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Detroit 4990729, Michigan 5001836 48201
The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Hackensack 5098706, New Jersey 5101760 07601
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Montefiore Einstein Comprehensive Cancer Center
The Bronx 5110266, New York 5128638 10461
The Bronx 5110266, New York 5128638 10461
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
OU Health Stephenson Cancer Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
University of Virginia
Charlottesville 4752031, Virginia 6254928 22903
Charlottesville 4752031, Virginia 6254928 22903
More Details
- NCT ID
- NCT06276491
- Status
- Recruiting
- Sponsor
- Xencor, Inc.