Safety and tolerability of XmAb541 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and tolerability of the investigational drug XmAb541 in patients with advanced solid tumors, specifically targeting ovarian cancer, endometrial cancer, and various germ cell tumors. The study aims to determine the optimal and safe dosage of XmAb541 while assessing its effects on tumor outcomes. Participants will be closely monitored for any adverse effects and overall response to the treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Winship Cancer Institute, Emory University
  Atlanta, Georgia, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: XmAb541-01 Central Contact
• Email: info541-01@xencor.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ARR-002 in advanced ovarian or endometrial cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.