Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05433142

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

Led by Xencor, Inc. · Updated on 2026-03-05

307

Participants Needed

23

Research Sites

337 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must have measurable disease by RECIST 1.1 criteria as assessed by the local investigator
  • Subjects must have relapsed and refractory clear cell renal cell carcinoma (ccRCC), papillary RCC (pRCC), non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) with disease progression on standard therapies
  • ECOG performance status must be 0 or 1
  • Adequate tumor sample must be available (slides or archival FFPE blocks)
Not Eligible

You will not qualify if you...

  • Prior treatment with investigational anti-ENPP3/CD203c therapy
  • History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
  • Received systemic antineoplastic therapy within 5 half-lives before first dose
  • Failure to recover from significant toxicity related to previous anticancer treatment
  • Known active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
  • Active known autoimmune disease, except specified exceptions managed without systemic therapy
  • Serious infection requiring IV anti-infective treatment within 14 days before first dose
  • Known additional malignancy that is progressing or required active treatment within past 2 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 23 locations

1

Xencor Investigative Site

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Xencor Investigative Site

Duarte, California, United States, 91010

Actively Recruiting

3

Xencor Investigative Site

Sacramento, California, United States, 95817

Actively Recruiting

4

Xencor Investigative Site

New Haven, Connecticut, United States, 06520

Actively Recruiting

5

Xencor Investigative Site

Jacksonville, Florida, United States, 32224

Actively Recruiting

6

Xencor Investigative Site

Atlanta, Georgia, United States, 30322

Actively Recruiting

7

Xencor Investigative Site

Chicago, Illinois, United States, 60611

Actively Recruiting

8

Xencor Investigative Site

Chicago, Illinois, United States, 60637

Actively Recruiting

9

Xencor Investigative Site

Louisville, Kentucky, United States, 40207

Actively Recruiting

10

Xencor Investigative Site

Rochester, Minnesota, United States, 55905

Actively Recruiting

11

Xencor Investigative Site

New Brunswick, New Jersey, United States, 088901

Actively Recruiting

12

Xencor Investigative Site

New York, New York, United States, 10032

Actively Recruiting

13

Xencor Investigative Site

New York, New York, United States, 10065

Actively Recruiting

14

Xencor Investigative Site

Charlotte, North Carolina, United States, 28777

Actively Recruiting

15

Xencor Investigative Site

Durham, North Carolina, United States, 27710

Actively Recruiting

16

Xencor Investigative Site

Cincinnati, Ohio, United States, 45267

Actively Recruiting

17

Xencor Investigative Site

Columbus, Ohio, United States, 43210

Actively Recruiting

18

Xencor Investigative Site

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

19

Xencor Investigative Site

Nashville, Tennessee, United States, 37203

Actively Recruiting

20

Xencor Investigative Site

Seattle, Washington, United States, 98109

Actively Recruiting

21

Xencor Investigative Site

Villejuif, France, 94805

Actively Recruiting

22

Xencor Investigative Site

Madrid, Spain, 28050

Actively Recruiting

23

Xencor Investigative Site

Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Actively Recruiting

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Research Team

C

Chet Bohac, MD

CONTACT

L

Lisa Finnigan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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