Treatment of advanced clear cell kidney cancer with XmAb®819

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xencor Investigative Site
  Phoenix, Arizona, United States Recruiting
• Xencor Investigative Site
  Duarte, California, United States Recruiting
• Xencor Investigative Site
  Sacramento, California, United States Recruiting
• Xencor Investigative Site
  New Haven, Connecticut, United States Recruiting
• Xencor Investigative Site
  Jacksonville, Florida, United States Recruiting
• Xencor Investigative Site
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: 819-01 Study Information
• Email: 819-01info@xencor.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• LNK001 CAR T therapy in advanced clear cell kidney cancer

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• Neoadjuvant immunotherapy with botensilimab and balstilimab for high-risk non-metastatic clear cell RCC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.