🏛️ Verified NIH Record • Updated 2026-07-31

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (NCT05433142)

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb819 in Subjects With Relapsed or Refractory Clear Cell Renal Cell Carcinoma

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Xencor, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).

Location: Xencor Investigative Site — Phoenix, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

  • Xencor Investigative Site — Phoenix, Arizona
  • Xencor Investigative Site — Duarte, California
  • Xencor Investigative Site — Sacramento, California
  • Xencor Investigative Site — New Haven, Connecticut
  • Xencor Investigative Site — Jacksonville, Florida
  • Xencor Investigative Site — Atlanta, Georgia
  • Xencor Investigative Site — Chicago, Illinois
  • Xencor Investigative Site — Chicago, Illinois
  • Xencor Investigative Site — Louisville, Kentucky
  • Xencor Investigative Site — Rochester, Minnesota
  • Xencor Investigative Site — New Brunswick, New Jersey
  • Xencor Investigative Site — New York, New York
  • Xencor Investigative Site — New York, New York
  • Xencor Investigative Site — Charlotte, North Carolina
  • Xencor Investigative Site — Durham, North Carolina
  • Xencor Investigative Site — Cincinnati, Ohio
  • Xencor Investigative Site — Columbus, Ohio
  • Xencor Investigative Site — Oklahoma City, Oklahoma
  • Xencor Investigative Site — Nashville, Tennessee
  • Xencor Investigative Site — Seattle, Washington
  • Xencor Investigative Site — Leuven,
  • Xencor Investigative Site — Bourdeaux,
  • Xencor Investigative Site — Villejuif,
  • Xencor Investigative Site — Barcelona,
  • Xencor Investigative Site — Madrid,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗