A Study of Sotorasib in People With Brain Tumors

May 21, 2026 updated by: Memorial Sloan Kettering Cancer Center

BrainMet ADePPT (Anticancer Drug Penetration Platform Trial)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Cameron Brennan, MD
  • Phone Number: 212-639-8268

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack (Limited protocol activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All protocol activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • Nelson Moss, MD
          • Phone Number: 212-639-7075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCOI naïve
Will receive the standard dose of sotorasib.
Drug: Sotorasib
Enrolled patients will be administered DCOI at the FDA-recommended dose or continued on the DCOI at the discretion of the treating Oncologist per standard of care
Other Names:
  • AMG 510
Active Comparator: Progressed on the DCOI
Will continue to receive the sotorasib dose they were previously receiving, according to their doctor's instruction.
Drug: Sotorasib
Enrolled patients will be administered DCOI at the FDA-recommended dose or continued on the DCOI at the discretion of the treating Oncologist per standard of care
Other Names:
  • AMG 510

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (overall response rate)
Time Frame: 1 year
defined as the sum of CR (complete response) rate plus PR (partial response) rate, assessed by RECIST 1.1.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Amgen

Investigators

  • Principal Investigator: Nelson Moss, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

February 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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