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Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Trial Status: active
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.
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06276491.
