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

June 9, 2026 updated by: Xencor, Inc.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: dose escalation, and dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC and other solid tumors. All eligible subjects will have relapsed or refractory disease after standard therapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Xencor Investigative Site
  • France
      • Bourdeaux, France, 33075
        • Recruiting
        • Xencor Investigative Site
      • Villejuif, France, 94805
        • Recruiting
        • Xencor Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Xencor Investigative Site
      • Madrid, Spain, 28050
        • Recruiting
        • Xencor Investigative Site
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Xencor Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Xencor Investigative Site
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Xencor Investigative Site
      • Sacramento, California, United States, 95817
        • Recruiting
        • Xencor Investigative Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Xencor Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Xencor Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Xencor Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Xencor Investigative Site
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Xencor Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Xencor Investigative Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Xencor Investigative Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 088901
        • Recruiting
        • Xencor Investigative Site
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Xencor Investigative Site
      • New York, New York, United States, 10065
        • Recruiting
        • Xencor Investigative Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28777
        • Recruiting
        • Xencor Investigative Site
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Xencor Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Xencor Investigative Site
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Xencor Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Xencor Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Xencor Investigative Site
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Xencor Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: XmAb819
Monoclonal Bispecific Antibody

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819)
Time Frame: 28 days
Safety and tolerability as assessed by incidence of TEAEs; incidence of clinically significant changes in safety laboratory tests, PE findings, vital signs, and ECGs; incidence and severity of CRS
28 days
Incidence of dose limiting toxicities (DLTs)
Time Frame: 28 days
Safety and tolerability as assessed by incidence of DLTs and all available data which will be used to determine the optimal dose regimen.
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measurement of Cmax
Time Frame: 56 days
Peak plasma concentration (Cmax)
56 days
Measurement of AUCtau
Time Frame: 56 days
Area under the plasma concentration versus time curve (AUCtau)
56 days
Objective Response rate
Time Frame: 42 days
Objective response rate (RECIST 1.1 assessment of CT/MRI imaging)
42 days
Progression-free survival
Time Frame: 42 days
Progression-free survival (RECIST 1.1 assessment of CT/MRI imaging)
42 days
Duration of response
Time Frame: 42 days
Duration of response (RECIST 1.1 assessment of CT/MRI imaging)
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xencor, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chet Bohac, MD, Xencor, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XmAb819-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clear Cell Renal Cell Carcinoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings