Recruiting
Phase 1

XmAb®819

Sponsor:

Xencor, Inc.

Code:

NCT05433142

Conditions

Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

XmAb819

Study Details

Brief 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).

Conditions

Clear Cell Renal Cell Carcinoma

Study ID

NCT05433142

Start date

Jun 13, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

307 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation and Expansion

Dose Escalation will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose.

Dose Expansion may administer XmAb819 IV, and XmAb819 SC.

Interventions

XmAb819

Monoclonal Bispecific Antibody

Primary outcome measure

  • Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) [ Time Frame: 28 days ]
  • Incidence of dose limiting toxicities (DLTs) [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

819-01 Study Information

819-01info@xencor.com

Locations

Xencor Investigative Site

Recruiting

Phoenix, Arizona, United States, 85054

Xencor Investigative Site

Recruiting

Duarte, California, United States, 91010

Xencor Investigative Site

Recruiting

Sacramento, California, United States, 95817

Xencor Investigative Site

Recruiting

New Haven, Connecticut, United States, 06520

Xencor Investigative Site

Recruiting

Jacksonville, Florida, United States, 32224

Xencor Investigative Site

Recruiting

Atlanta, Georgia, United States, 30322

Xencor Investigative Site

Recruiting

Chicago, Illinois, United States, 60611

Xencor Investigative Site

Recruiting

Chicago, Illinois, United States, 60637

Xencor Investigative Site

Recruiting

Louisville, Kentucky, United States, 40207

Xencor Investigative Site

Recruiting

Rochester, Minnesota, United States, 55905

Xencor Investigative Site

Recruiting

New Brunswick, New Jersey, United States, 088901

Xencor Investigative Site

Recruiting

New York, New York, United States, 10032

Xencor Investigative Site

Recruiting

New York, New York, United States, 10065

Xencor Investigative Site

Recruiting

Charlotte, North Carolina, United States, 28777

Xencor Investigative Site

Recruiting

Durham, North Carolina, United States, 27710

Xencor Investigative Site

Recruiting

Cincinnati, Ohio, United States, 45267

Xencor Investigative Site

Recruiting

Columbus, Ohio, United States, 43210

Xencor Investigative Site

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Xencor Investigative Site

Recruiting

Nashville, Tennessee, United States, 37203

Xencor Investigative Site

Recruiting

Seattle, Washington, United States, 98109

More Information

Sponsor

Xencor, Inc.

Last update posted

Aug 3, 2026

Last verified

Jun, 2026

Keywords

  • Clear cell Papillary
  • RCC
  • Renal Cell Cancer
  • Kidney Cancer
  • Lung Cancer
  • Colon Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Xencor, Inc. on 2026-08-03.