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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age15+
SponsorXencor, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Patients 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

Trial design

Treatments tested in this trial

  • XmAb541

Treatment groups

282 Participants
are divided into 1 treatment group

Sponsors and collaborators