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
Key Inclusion Criteria: * Age ≥ 18 years. For 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: * Patients with treated brain metastases may partici…
Interventions
- BiologicalXmAb541
Monoclonal bispecific antibody
Locations (16)
- City of HopeDuarte, California
- StanfordPalo Alto, California
- University of CaliforniaSan Francisco, California
- Moffitt Cancer CenterTampa, Florida
- Winship Cancer Institute, Emory UniversityAtlanta, Georgia
- University of Chicago Medical CenterChicago, Illinois