A Study of Sotorasib in People With Brain Tumors

Inclusion criteria

• Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy
• Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy
• For all cohorts: no limit on prior CNS radiation or systemic therapyKPS ≥ 60
• Life expectancy >12 weeks
• Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator
• Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):

• Absolute neutrophil count (ANC) ≥1.0 × 10^3/μL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)
• Platelet count ≥10.0x10^4/μL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x10^4/μL are not eligible. (Platelet transfusion is not allowed within 1 week prior to C1D1)
• Hemoglobin ≥ 7.0 g/dL (≥ 8 g/dL in gastric cancer / gastroesophageal cancer indications). Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible (Red blood cell transfusion is not allowed within 1 week prior to C1D1)
• Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (<5x ULN in participants with liver metastases)
• Total bilirubin ≤1.5 × ULN) if no liver metastases or <3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline

Exclusion criteria

• Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the Principal Investigator; reactions will be managed per standard institutional protocol
• Multiple primary malignancies within 3 years, with the exception of:

• adequately resected non-melanoma skin cancer
• carcinoma in situ of the cervix
• Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider
• curatively treated in-situ disease
• other solid tumors curatively treated
• for patients with metastatic breast cancer: contralateral breast cancer