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Taking people in United KingdomPhase 1

Tests XmAb541 for safety in people with advanced solid tumors

Tests the new drug XmAb541 for safety and dosing in advanced ovarian and endometrial cancers.

Key facts

Who runs it
Xencor, Inc.
Where
Manchester, United KingdomSee the siteAlso in 5 other countries, 26 sites
Trial code
Registry title
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1
People taking part
282 people, planned
Started
4 Apr 2024
Expected to end
Dec 2028
Type of study
Interventional
Treatments tested
  • XmAb541
Record updated
9 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced ovarian, fallopian tube, peritoneal, endometrial or germ cell tumors that carry CLDN6 and have come back, spread or stopped responding to treatment.

Age
18 years or older. In the US only, people with germ cell tumors can join from age 15.
Sex
All sexes can join.
Disease stage
Locally advanced, recurrent or metastatic ovarian, fallopian tube or peritoneal cancer, or endometrial (uterine) cancer. Germ cell tumors that did not respond to earlier treatment are also accepted.
Earlier treatment
Germ cell tumors must be resistant to previous treatment.
Biomarker or test result
The tumor must be CLDN6+ (CLDN6 positive).

Main reasons for not taking part

  • Untreated brain metastases (treated ones can join if stable on scans)
  • Active known or suspected autoimmune disease
  • Needing steroids or other immune-suppressing medicines within 14 days before the first dose
  • Clinically significant heart, lung or digestive disease
  • Active hepatitis B or hepatitis C

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
  • Active known or suspected autoimmune disease
  • Clinically significant cardiovascular, pulmonary or gastrointestinal disease
  • Active hepatitis B or hepatitis C
  • Participants with untreated brain metastases are excluded. Participants with treated brain metastases may participate, provided they are radiologically stable

Where in United Kingdom

Also in 5 other countries, 26 sites

  • The Christie NHS Foundation TrustManchester, United KingdomTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Dose escalation and Dose Expansion of XmAb541Treatment being tested

    Intravenous or Subcutaneous administration

    Treatment: XmAb541

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
Plain-language title
Tests XmAb541 for safety in people with advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 October 2026