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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 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
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, 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
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
Positive test for hepatitis C RNA
Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)
Additional locations may be listed on ClinicalTrials.gov for NCT06276491.
