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.
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
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
Sequential
XmAb541
Biological/VaccineMonoclonal bispecific antibody
Incidence of adverse events
Incidence of dose-limiting toxicities (DLTs)
Incidence of cytokine release syndrome (CRS)
Measurement of Cmax
Peak plasma concentration
Measurement of area under curve (AUC)
Area under the plasma concentration versus time curve
Measurement of Ctrough
Plasma concentration before next dose
Objective Response Rate
Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
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