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New hope for kidney cancer: experimental drug XmAb819 enters human trials

NCT ID NCT05433142

Disease control Sponsor: Xencor, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called XmAb819 in people with advanced clear cell kidney cancer that has come back or not responded to standard treatments. The main goal is to check the drug's safety and find the best dose. About 307 participants will receive the drug intravenously or as a shot under the skin.

Why investors are watching

Xencor is testing XmAb819, an experimental drug, in 307 patients with a type of kidney cancer that has returned or stopped responding to treatment. This phase 1 trial measures safety and finds the right dose, and for a small company like Xencor, the result will show whether the drug is worth advancing. A clear safety profile and signs of disease control would validate the company's pipeline.

If it works: A positive result could show that XmAb819 is safe and has biological activity, which would support moving the drug into later-stage trials. That progress could strengthen Xencor's position as a developer of cancer treatments.

If it fails: Phase 1 trials often fail because the drug proves too toxic or shows no benefit, and a poor outcome could set back Xencor's development plans for this drug. Delays in enrollment or dosing could also slow the program and consume resources.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 307 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

colonic neoplasm kidney cancer lung neoplasm nonpapillary renal cell carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Clear cell renal cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Xencor Investigative Site

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Xencor Investigative Site

    RECRUITING

    Duarte, California, 91010, United States

  • Xencor Investigative Site

    RECRUITING

    Sacramento, California, 95817, United States

  • Xencor Investigative Site

    RECRUITING

    New Haven, Connecticut, 06520, United States

  • Xencor Investigative Site

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Xencor Investigative Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Xencor Investigative Site

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Xencor Investigative Site

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Xencor Investigative Site

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Xencor Investigative Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Xencor Investigative Site

    RECRUITING

    New Brunswick, New Jersey, 088901, United States

  • Xencor Investigative Site

    RECRUITING

    New York, New York, 10032, United States

  • Xencor Investigative Site

    RECRUITING

    New York, New York, 10065, United States

  • Xencor Investigative Site

    RECRUITING

    Charlotte, North Carolina, 28777, United States

  • Xencor Investigative Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Xencor Investigative Site

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • Xencor Investigative Site

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Xencor Investigative Site

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Xencor Investigative Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Xencor Investigative Site

    RECRUITING

    Seattle, Washington, 98109, United States

  • Xencor Investigative Site

    RECRUITING

    Leuven, 3000, Belgium

  • Xencor Investigative Site

    RECRUITING

    Bourdeaux, 33075, France

  • Xencor Investigative Site

    RECRUITING

    Villejuif, 94805, France

  • Xencor Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Xencor Investigative Site

    RECRUITING

    Madrid, 28050, Spain

  • Xencor Investigative Site

    RECRUITING

    Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

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