ClinicalTrials.gg
RecruitingNCT06276491Updated Oct 9, 2026

Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

A Phase 1 interventional study of XmAb541 in Ovarian Cancer, Endometrial Cancer and Germ Cell Tumor, sponsored by Xencor, Inc.. Recruiting at 27 sites in 6 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Xencor, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Updated Oct 9, 2026First sites in France and United Kingdom8 sites added+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
282
Allocation
Not applicable
Ages
15 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.

02

Conditions studied

  • Ovarian Cancer
  • Endometrial Cancer
  • Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • Ovarian Germ Cell Tumor

Keywords

  • Phase 1
  • Ovarian Cancer
  • CLDN6
  • Testicular Cancer
  • Germ Cell Tumor
  • Endometrial Cancer
  • T-cell Engager
03

In context

Ovarian Neoplasms

3,381 studies on the registry are indexed under Ovarian Neoplasms; 790 are open to participants now.

This study's planned enrollment of 282 is above the median of 54 across 2,548 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Xencor, Inc. is the lead sponsor of 30 studies on the registry; 7 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 2 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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 performance status
  • ≥ 3 months
  • Adequate liver, kidney, and bone marrow function

Key Exclusion Criteria:

  • Participants with untreated are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable.
  • Active known or suspected disease
  • Have any condition requiring systemic treatment with , prednisone equivalents, or other medications within 14 days prior to first dose of study drug
  • cardiovascular, pulmonary or gastrointestinal disease
  • Active or
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
282 participants (estimated)

Study arms

  • Experimental
    Dose escalation and Dose Expansion of XmAb541

    Intravenous or Subcutaneous administration

    Biological: XmAb541

Interventions

  • BiologicalXmAb541

    Monoclonal bispecific antibody

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

    Time frame: Day 1 to 2 years

  2. Incidence of dose-limiting toxicities (DLTs)

    Time frame: Day 1 to Day 28

  3. Incidence of cytokine release syndrome (CRS)

    Time frame: Day 1 to Day 28

Secondary outcomes

  1. Measurement of Cmax

    Peak plasma concentration

    Time frame: Day 1 to 2 years

  2. Measurement of area under curve (AUC)

    Area under the plasma concentration versus time curve

    Time frame: Day 1 to 1.4 years

  3. Measurement of Ctrough

    Plasma concentration before next dose

    Time frame: Day 1 to 2 years

  4. Objective Response Rate

    Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging

    Time frame: Day 1 to 2 years

  5. Duration of Response

    Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging

    Time frame: Day 1 to 2 years

  6. Changes in Circulating Tumor DNA (ctDNA)

    Maximum variant frequency or mean/median variant frequency

    Time frame: Day 1 to 4 months

07

Study locations

27 of 27 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
8 sites added, 3 sites removed — first sites in France and United Kingdom
Show 8 added (3 United States, 2 Spain, 1 Belgium, 1 France, 1 United Kingdom)
  • Stanford University · Palo Alto, United States
  • University of California San Francisco · San Francisco, United States
  • The John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, United States
  • UZ Leuven · Leuven, Belgium
  • Centre Hospitalier Lyon-Sud · Pierre-Bénite, France
  • Clinical Universidad de Navarra · Madrid, Spain
  • Clinical Universidad de Navarra · Pamplona, Spain
  • The Christie NHS Foundation Trust · Manchester, United Kingdom
Show 3 removed
  • Stanford · Palo Alto, United States
  • University of California · San Francisco, United States
  • The John Theruer Cancer Center at Hackensack University Medical Center · Hackensack, United States
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    8 sites added, 3 sites removed — first sites in France and United Kingdom
    Show 8 added (3 United States, 2 Spain, 1 Belgium, 1 France, 1 United Kingdom)
    • Stanford University · Palo Alto, United States
    • University of California San Francisco · San Francisco, United States
    • The John Theurer Cancer Center at Hackensack University Medical Center · Hackensack, United States
    • UZ Leuven · Leuven, Belgium
    • Centre Hospitalier Lyon-Sud · Pierre-Bénite, France
    • Clinical Universidad de Navarra · Madrid, Spain
    • Clinical Universidad de Navarra · Pamplona, Spain
    • The Christie NHS Foundation Trust · Manchester, United Kingdom
    Show 3 removed
    • Stanford · Palo Alto, United States
    • University of California · San Francisco, United States
    • The John Theruer Cancer Center at Hackensack University Medical Center · Hackensack, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06276491
Lead sponsor
Xencor, Inc.
Responsible party
Sponsor
First posted
Feb 26, 2024
Start date
Apr 4, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 9, 2026

Study contacts

XmAb541-01 Central Contact
Contact
info541-01@xencor.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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