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Phase 1 Study of XmAb541 for Advanced Solid Tumors

This study is testing a new investigational drug called XmAb541 for people with advanced ovarian cancer, endometrial cancer, or germ cell tumors (a type of cancer that starts in reproductive cells). The main goals are to find out if XmAb541 is safe, how well people tolerate it, and to determine the best dose for future studies. Researchers will also look at how XmAb541 affects tumor growth. To join, you must have a tumor that tests positive for CLDN6 and has not responded to previous treatments. The study is currently recruiting participants.

Study design
This is a Phase 1 study, meaning it's an early-stage study to test safety and dosage. It plans to enroll up to 282 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track adverse events (side effects) for up to 2 years after starting treatment, and dose-limiting toxicities and cytokine release syndrome for 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06276491

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

Recruiting
PHASE1Ages 15+InterventionalTreatment
Xencor, Inc.
~282 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:XmAb541

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Day 1 to 2 years
+2 more outcomes measured

Conditions

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

Explore related trials

Endometrial CarcinomaFallopian Tube CarcinomaGerm Cell TumorMalignant Ovarian NeoplasmMalignant Peritoneal NeoplasmSolid NeoplasmCLDN6 Gene

Where it's being run

22 sites across 17 states
California3
New York2
Belgium2
Spain2
Florida1
Georgia1
Illinois1
Indiana1

Who to contact

XmAb541-01 Central Contact
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Incidence of adverse eventsDay 1 to 2 years
  • Incidence of dose-limiting toxicities (DLTs)Day 1 to Day 28
  • Incidence of cytokine release syndrome (CRS)Day 1 to Day 28