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Monoclonal Antibodies

XmAb541 for Cancer

Phase 1
Recruiting
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of 0-2
Age ≥ 18 years. For subjects with GCTs, age ≥15 years
Must not have
Prior exposure to a CLDN6 targeting product
Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a new drug, XmAb541, to see if it is safe and well-tolerated. Researchers also want to find the best and safest dose of the drug for future

Who is the study for?
Adults with advanced solid tumors, specifically ovarian, fallopian tube, peritoneal cancer, endometrial cancer or germ cell tumors (GCT), who have progressive disease despite standard treatments. Participants must be over 18 years old (15 for GCT), have good organ function and a life expectancy of at least 3 months.
What is being tested?
The trial is testing the safety and tolerability of XmAb541 to find the best dose for future studies. It will also assess how well XmAb541 works against these types of cancers.
What are the potential side effects?
As this is an early-phase study primarily focused on safety and optimal dosing, specific side effects are not listed but may include typical reactions to new cancer drugs such as fatigue, nausea, inflammation or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I am at least 18 years old, or at least 15 with germ cell tumors.
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My cancer is advanced and affects the ovaries, fallopian tubes, peritoneum, endometrium, or GCT.
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My tumor tests positive for CLDN6.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with a CLDN6 targeting drug before.
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My ovarian cancer did not respond to platinum treatment or worsened quickly after my last cancer therapy.
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I have a serious heart, lung, or stomach/intestine condition.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Changes in Circulating Tumor DNA (ctDNA)
Duration of Response
Measurement of Cmax
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalation and Dose Expansion of XmAb541Experimental Treatment1 Intervention
Intravenous or Subcutaneous administration

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Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
30 Previous Clinical Trials
2,440 Total Patients Enrolled
~141 spots leftby Dec 2027
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