A Study of Sotorasib in People With Brain Tumors

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called sotorasib to see how well it works for people with specific types of brain tumors that have a genetic change known as KRAS G12C+. The researchers are particularly interested in whether sotorasib is safe and effective for patients who are about to have surgery to remove these tumors. They will also look at how the body processes the medication. The trial is currently recruiting participants aged 18 and older who have one or more brain tumors that need surgical treatment.

To be eligible for the trial, patients should be adults with brain tumors that require surgery and should have a good chance of living for at least 12 weeks. Importantly, there are specific health requirements related to blood counts and organ function that must be met, as well as certain prior treatment guidelines. Participants in the trial will receive sotorasib and will be monitored closely for any side effects and how well the drug works. This study is an important step in finding new treatment options for patients with these challenging brain tumors.

Gender

ALL

Eligibility criteria

• 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