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New antibody drug enters first human tests for tough cancers

NCT ID NCT06276491

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This early-stage trial is testing a new drug called XmAb541 in people with advanced ovarian, endometrial, or germ cell tumors that have not responded to standard treatments. The main goal is to see if the drug is safe and to find the best dose. About 282 participants will receive the drug, and researchers will monitor for side effects and any tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XmAb541 (a bispecific antibody)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced ovarian, endometrial, or germ cell tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the main goal is safety, not effectiveness. The drug may cause side effects like cytokine release syndrome, and it may not shrink tumors.

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 282 people

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

Started

Apr 2024

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

15 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.

Key Inclusion Criteria: * Age ≥ 18 years. For US only: subjects with GCTs, age ≥15 years * CLDN6+ tumor * Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT resistant to previous treatment * Adequate Eastern Cooperative Oncology Group performance status * Life expectancy ≥ 3 months * Adequate liver, kidney, and bone marrow function Key Exclusion Criteria: * Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable. * Active known or suspected autoimmune disease * Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug * Clinically significant cardiovascular, pulmonary or gastrointestinal disease * Active hepatitis B or hepatitis C

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm fallopian tube cancer germ cell tumor Neoplasms, Germ Cell and Embryonal ovarian cancer ovarian germ cell tumor peritoneum cancer testicular cancer testicular germ cell tumor

As listed by the trial registrant

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

Endometrial cancer Germ cell tumor Ovarian cancer Ovarian germ cell tumor Testicular germ cell tumor

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

    22 sites in 4 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

  • AZ Groeninge

    RECRUITING

    Kortrijk, 8500, Belgium

  • CHU de Liege

    RECRUITING

    Liège, 4000, Belgium

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Herlev Gentofte Hospital

    RECRUITING

    Herlev, 2730, Denmark

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Einstein Comprehensive Cancer Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • NEXT Oncology - Hospital Quironsalud

    RECRUITING

    Barcelona, 08023, Spain

  • NEXT Oncology - Hospital Quironsalud

    RECRUITING

    Madrid, 28223, Spain

  • OU Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Stanford

    RECRUITING

    Palo Alto, California, 94304, United States

  • The John Theruer Cancer Center at Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of California

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Winship Cancer Institute, Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.