Actively Recruiting
BrainMet ADePPT (Anticancer Drug Penetration Platform Trial) of Sotorasib in People With KRAS G12C+ Brain Tumors Undergoing Surgical Resection
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-22
16
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
Amgen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of sotorasib in treating brain tumors that have the KRAS G12C mutation. This study aims to understand how well sotorasib reaches these metastatic brain tumors during surgical removal, and to assess the safety and effectiveness of the treatment. Additionally, the study will examine how the body absorbs, distributes, and eliminates sotorasib. Participants will receive sotorasib either at the standard FDA-recommended dose or continue with their current dose as directed by their doctor. The study includes adults undergoing neurosurgical resection or biopsy of one or more brain tumors, including those with leptomeningeal metastasis if they require brain tumor surgery. There is no limit on previous radiation or systemic therapy, and treatment will follow standard care guidelines. During the study, participants will have assessments of tumor response over the course of one year, including monitoring of overall response rate. Safety and treatment effects will be closely observed through regular clinical evaluations and laboratory tests to measure blood counts, kidney and liver function, and other health parameters. The trial is non-randomized and open-label, with the Memorial Sloan Kettering Cancer Center leading the study, and participation will last as long as the treatment and follow-up periods extend.
CONDITIONS
Brief Title
A Study of Sotorasib in People With Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older with one or more brain tumors planned for neurosurgical resection or biopsy
- Patients with leptomeningeal metastasis are eligible if they have brain tumors requiring surgery or biopsy
- No limit on prior central nervous system radiation or systemic therapy
- Karnofsky Performance Status (KPS) of 60 or higher
- Life expectancy greater than 12 weeks
- Adequate recovery from prior treatments as judged by the investigator
- Adequate bone marrow, kidney, liver, and coagulation function within 7 days before starting treatment, including specific blood count and liver enzyme requirements
You will not qualify if you...
- Known allergy or hypersensitivity to sotorasib or any study drug ingredients
- Allergy to gadolinium-based agents without premedication or alternative imaging
- Multiple primary cancers within 3 years except certain treated or low-risk cancers such as non-melanoma skin cancer, cervical carcinoma in situ, smoldering pre-malignant conditions like CLL or MGUS, curatively treated in-situ disease, other solid tumors treated curatively, or contralateral breast cancer in metastatic breast cancer patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants receive sotorasib as the investigational drug treatment according to their assigned group, either starting the standard dose or continuing their current dose under their doctor's instruction.
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Nelson Moss, MD
C
Cameron Brennan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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