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

Xencor, Inc.

Summary

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

Age range: 15+ years
Sex: All
Healthy volunteers: No

Detailed 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 metasta…

Locations (22)

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

Summary

Eligibility

Interventions

Locations (22)