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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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, pRCC, NSCLC, and CRC 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
Primary outcome measure(s)
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) — 28 days Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
Incidence of dose limiting toxicities (DLTs) — 28 days Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
Trial sites (26)
Facility
City
Region
Status
Xencor Investigative Site
Phoenix
Arizona
Recruiting
Xencor Investigative Site
Duarte
California
Recruiting
Xencor Investigative Site
Sacramento
California
Recruiting
Xencor Investigative Site
New Haven
Connecticut
Recruiting
Xencor Investigative Site
Jacksonville
Florida
Recruiting
Xencor Investigative Site
Atlanta
Georgia
Recruiting
Xencor Investigative Site
Chicago
Illinois
Recruiting
Xencor Investigative Site
Chicago
Illinois
Recruiting
Xencor Investigative Site
Louisville
Kentucky
Recruiting
Xencor Investigative Site
Rochester
Minnesota
Recruiting
Xencor Investigative Site
New Brunswick
New Jersey
Recruiting
Xencor Investigative Site
New York
New York
Recruiting
Xencor Investigative Site
New York
New York
Recruiting
Xencor Investigative Site
Charlotte
North Carolina
Recruiting
Xencor Investigative Site
Durham
North Carolina
Recruiting
Xencor Investigative Site
Cincinnati
Ohio
Recruiting
Xencor Investigative Site
Columbus
Ohio
Recruiting
Xencor Investigative Site
Oklahoma City
Oklahoma
Recruiting
Xencor Investigative Site
Nashville
Tennessee
Recruiting
Xencor Investigative Site
Seattle
Washington
Recruiting
Xencor Investigative Site
Leuven
Belgium
Recruiting
Xencor Investigative Site
Bourdeaux
France
Recruiting
Xencor Investigative Site
Villejuif
France
Recruiting
Xencor Investigative Site
Barcelona
Spain
Recruiting
Xencor Investigative Site
Madrid
Spain
Recruiting
Xencor Investigative Site
Cambridge
Cambridgeshire
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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