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Treatment of advanced clear cell kidney cancer with XmAb®819

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

Phase 1 Interventional Xencor, Inc. · NCT05433142

This study is testing a new drug called XmAb®819 to see if it’s safe and effective for people with advanced clear cell kidney cancer who haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment307 (estimated)
Ages18 Years and up
SexAll
SponsorXencor, Inc. Industry-sponsored
Locations23 sites (Phoenix, Arizona and 22 other locations)
Trial IDNCT05433142 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety and tolerability of XmAb®819 in patients with relapsed or refractory clear cell renal cell carcinoma. The study is divided into two parts: a dose escalation phase to determine the minimum safe and biologically active dose, and a dose expansion phase to further assess the drug's effects. Participants will receive XmAb®819 either intravenously or subcutaneously, and the study will also examine pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Eligible patients must have measurable disease and have previously undergone standard therapies.

Who should consider this trial

Good fit: Ideal candidates include individuals with measurable relapsed or refractory clear cell renal cell carcinoma who have progressed after standard therapies.

Not a fit: Patients with active central nervous system metastases or those who have had prior treatment with investigational anti-ENPP3/CD203c therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced clear cell renal cell carcinoma who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific treatment is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Phoenix, Arizona and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Clear Cell Renal Cell CarcinomaClear cell PapillaryRCCRenal Cell CancerKidney CancerLung CancerColon Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.