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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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).

What is being tested

Sponsor: Xencor, Inc. · Participants: 307 · Started: Jun 13, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05433142

Locations in the U.S.

ArizonaXencor Investigative Site, Phoenix
CaliforniaXencor Investigative Site, Duarte
Xencor Investigative Site, Sacramento
ConnecticutXencor Investigative Site, New Haven
FloridaXencor Investigative Site, Jacksonville
GeorgiaXencor Investigative Site, Atlanta
IllinoisXencor Investigative Site, Chicago
Xencor Investigative Site, Chicago
KentuckyXencor Investigative Site, Louisville
MinnesotaXencor Investigative Site, Rochester
New JerseyXencor Investigative Site, New Brunswick
New YorkXencor Investigative Site, New York
Xencor Investigative Site, New York
North CarolinaXencor Investigative Site, Charlotte
Xencor Investigative Site, Durham
OhioXencor Investigative Site, Cincinnati
Xencor Investigative Site, Columbus
OklahomaXencor Investigative Site, Oklahoma City
TennesseeXencor Investigative Site, Nashville
WashingtonXencor Investigative Site, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.