A Study of Sotorasib in People With Brain Tumors
Recruiting now · Phase 1
Conditions studied: Brain Tumor
In brief
The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.
Key facts
- Study ID
- NCT06807619
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 16
- Starts
- 2025-01-29
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering West Harrison (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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