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Clinical Trials in the UK / NCT05433142
Recruiting Phase 1

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

NCT05433142 · tracked via the Priya Life Science UK tracker
Sponsor
Xencor, Inc.
Phase
Phase 1
Started
2022-06-13
Last updated
2026-08-03

Condition(s) studied

Clear Cell Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

XmAb819

XmAb819: Monoclonal Bispecific Antibody

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Xencor Investigative Site Phoenix Arizona Recruiting
Xencor Investigative Site Duarte California Recruiting
Xencor Investigative Site Sacramento California Recruiting
Xencor Investigative Site New Haven Connecticut Recruiting
Xencor Investigative Site Jacksonville Florida Recruiting
Xencor Investigative Site Atlanta Georgia Recruiting
Xencor Investigative Site Chicago Illinois Recruiting
Xencor Investigative Site Chicago Illinois Recruiting
Xencor Investigative Site Louisville Kentucky Recruiting
Xencor Investigative Site Rochester Minnesota Recruiting
Xencor Investigative Site New Brunswick New Jersey Recruiting
Xencor Investigative Site New York New York Recruiting
Xencor Investigative Site New York New York Recruiting
Xencor Investigative Site Charlotte North Carolina Recruiting
Xencor Investigative Site Durham North Carolina Recruiting
Xencor Investigative Site Cincinnati Ohio Recruiting
Xencor Investigative Site Columbus Ohio Recruiting
Xencor Investigative Site Oklahoma City Oklahoma Recruiting
Xencor Investigative Site Nashville Tennessee Recruiting
Xencor Investigative Site Seattle Washington Recruiting
Xencor Investigative Site Leuven Belgium Recruiting
Xencor Investigative Site Bourdeaux France Recruiting
Xencor Investigative Site Villejuif France Recruiting
Xencor Investigative Site Barcelona Spain Recruiting
Xencor Investigative Site Madrid Spain Recruiting
Xencor Investigative Site Cambridge Cambridgeshire Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05433142 on ClinicalTrials.gov ↗ ← All trials in the UK