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Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
Trial Status: active
The purpose of this study is to assess the safety and tolerability of XmAb®819
administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or
refractory clear cell renal cell carcinoma and to identify the minimum safe and
biologically active dose and the recommended dose (RD).
Inclusion Criteria
Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
ECOG performance status of 0 or 1.
All subjects must have adequate tumor sample available (slides or archival FFPE blocks)
Exclusion Criteria
Prior treatment with an investigational anti-ENPP3/CD203c therapy
History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
Failure to recover from any clinically significant toxicity related to previous anticancer treatment
Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
Have a known additional malignancy that is progressing or has required active treatment within the past 2 years
Additional locations may be listed on ClinicalTrials.gov for NCT05433142.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Sacramento
University of California Davis Comprehensive Cancer Center
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Illinois
Chicago
Northwestern University
Status: Active
Name Not Available
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Status: Active
Name Not Available
North Carolina
Charlotte
Carolinas Medical Center/Levine Cancer Institute
Status: Active
Name Not Available
Durham
Duke University Medical Center
Status: Active
Name Not Available
Ohio
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Status: Active
Name Not Available
This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part
A, dose escalation, and Part B, dose expansion. The study is designed to establish the
dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819
administered SC. The study is designed to evaluate safety and tolerability; to assess
PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in
subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after