M.D. Anderson Cancer Center
The goal of this clinical research study is to learn if zanzalintinib can help to control recurrent/metastatic ONB. The safety of zanzalintinib will also be studied.
Primary Objectives: • To assess the efficacy of Zanzalintinib in patients with R/M ONB Endpoint ORR, defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) as measured by response evaluation criteria in solid tumors (RECIST), version 1.1, as determined by investigator radiologist assessment. Secondary Objectives: • To assess the metabolic response of Zanzalintinib in patients with R/M ONB Endpoint Objective Metabolic Response Rate (OMRR), defined as the proportion of patients who achieve a complete metabolic response (CMR) or partial metaboli…
Inclusion Criteria: All subjects must meet all the following inclusion criteria to be eligible for participation in this study: 1. Subjects ≥18 years with histology-proven R/M ONB. 2. Not amenable to curative intent surgery or radiotherapy 3. Measurable disease per RECIST 1.1 4. Performance status ECOG of 0 or 1 5. VEGFR-inhibitor naïve (R/M ONB never treated with VEGFR inhibitors including Zanzalintinib) 6. Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 14 days before first dose of study treatment 1. Hemoglobin ≥ 9 g/dL without transf…
Given orally
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