Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors
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 effect of XmAb541 on tumor outcomes.
- EligibilityCriteria: Key Inclusion Criteria:  Age ≥ 18 years. For subjects with GCTs, age ≥15 years CLDN6+ tumor Histological evidence of locally advanced, recurrent, or metastatic solid malignancy Ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy. Eastern Cooperative Oncology Group performance status of 0-2 Life expectancy ≥ 3 months Adequate liver, kidney, thyroid and bone marrow function  Key Exclusion Criteria:  Prior exposure to a CLDN6 targeting product Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable. Active known or suspected autoimmune disease Has 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 Known Human immunodeficiency virus (HIV) positivity Positive test for hepatitis C RNA Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb) - HealthyVolunteers: No - Gender: All - MinimumAge: 15 Years - StdAgeList: Child, Adult, Older Adult