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A Study of Sotorasib for Brain Tumors with KRAS G12C Mutation

This study is looking at sotorasib, a medication, in people with brain tumors. Researchers want to see how well sotorasib gets into brain tumors that have a specific genetic change called KRAS G12C. They also want to find out if sotorasib is a safe and effective treatment for these tumors, especially for people having surgery. You might be able to join if you are an adult (18 or older) with a brain tumor needing surgery or biopsy, and have a KRAS G12C mutation. The main goal is to measure the overall response rate (how much the tumor shrinks or disappears) after one year. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 16 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the overall response rate at 1 year, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06807619

A Study of Sotorasib in People With Brain Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~16 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Sotorasib

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ORR (overall response rate)
Measured over 1 year

Conditions

Brain Tumor

Explore related trials

Brain NeoplasmGTPase KRas

Where it's being run

7 sites across 2 states
New York5
New Jersey2

Study leadership

  • Nelson Moss, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Nelson Moss, MD
[email protected]
212-639-7075
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • ORR (overall response rate)1 year

    defined as the sum of CR (complete response) rate plus PR (partial response) rate, assessed by RECIST 1.1.