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NCT05433142PHASE1Recruiting

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Xencor, Inc.

Start Date

6/13/2022

Completion Date

12/1/2028

Summary

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).

Detailed Description

This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: dose escalation, and 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 and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

BIOLOGICAL

XmAb819

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Conditions

Clear Cell Renal Cell Carcinoma

Locations

Xencor Investigative Site

Phoenix, Arizona 85054

United States

Xencor Investigative Site

Duarte, California 91010

United States

Xencor Investigative Site

Sacramento, California 95817

United States

Xencor Investigative Site

New Haven, Connecticut 06520

United States

Xencor Investigative Site

Jacksonville, Florida 32224

United States

Xencor Investigative Site

Atlanta, Georgia 30322

United States

Xencor Investigative Site

Chicago, Illinois 60611

United States

Xencor Investigative Site

Chicago, Illinois 60637

United States

Xencor Investigative Site

Louisville, Kentucky 40207

United States

Xencor Investigative Site

Rochester, Minnesota 55905

United States

Xencor Investigative Site

New Brunswick, New Jersey 088901

United States

Xencor Investigative Site

New York, New York 10032

United States

Xencor Investigative Site

New York, New York 10065

United States

Xencor Investigative Site

Charlotte, North Carolina 28777

United States

Xencor Investigative Site

Durham, North Carolina 27710

United States

Xencor Investigative Site

Cincinnati, Ohio 45267

United States

Xencor Investigative Site

Columbus, Ohio 43210

United States

Xencor Investigative Site

Oklahoma City, Oklahoma 73104

United States

Xencor Investigative Site

Nashville, Tennessee 37203

United States

Xencor Investigative Site

Seattle, Washington 98109

United States

Xencor Investigative Site

Leuven, 3000

Belgium

Xencor Investigative Site

Bourdeaux, 33075

France

Xencor Investigative Site

Villejuif, 94805

France

Xencor Investigative Site

Barcelona, 08035

Spain

Xencor Investigative Site

Madrid, 28050

Spain

Xencor Investigative Site

Cambridge, Cambridgeshire CB2 0QQ

United Kingdom