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

RecruitingPhase 1

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

Who can join

Ages 15 and older · All sexes

Full 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 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

About the study

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.

What is being tested

Sponsor: Xencor, Inc. · Participants: 282 · Started: Apr 4, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06276491

Locations in the U.S.

CaliforniaCity of Hope, Duarte
Stanford, Palo Alto
University of California, San Francisco
FloridaMoffitt Cancer Center, Tampa
GeorgiaWinship Cancer Institute, Emory University, Atlanta
IllinoisUniversity of Chicago Medical Center, Chicago
IndianaIndiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis
MichiganKarmanos Cancer Institute, Detroit
MinnesotaUniversity of Minnesota, Minneapolis
New JerseyThe John Theruer Cancer Center at Hackensack University Medical Center, Hackensack
New YorkIcahn School of Medicine at Mount Sinai, New York
Montefiore Einstein Comprehensive Cancer Center, The Bronx
OhioThe Ohio State University, Columbus
OklahomaOU Health Stephenson Cancer Center, Oklahoma City
PennsylvaniaUPMC Hillman Cancer Center, Pittsburgh
TennesseeSCRI Oncology Partners, Nashville
VirginiaUniversity of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.