Recruiting
Phase 1

Sotorasib

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06807619

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sotorasib

Study Details

Brief summary:

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.

Conditions

Brain Tumor

Study ID

NCT06807619

Start date

Jan 29, 2025

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DCOI naïve

Will receive the standard dose of sotorasib.

active comparator: Progressed on the DCOI

Will continue to receive the sotorasib dose they were previously receiving, according to their doctor's instruction.

Interventions

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

Primary outcome measure

  • ORR (overall response rate) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Nelson Moss, MD

212-639-7075mossn@mskcc.org

Cameron Brennan, MD

212-639-8268

Locations

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Nelson Moss, MD

212-639-7075

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Nelson Moss, MD

212-639-7075

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Nelson Moss, MD

212-639-7075

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Nelson Moss, MD

212-639-7075

Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Nelson Moss, MD

212-639-7075

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Nelson Moss, MD

212-639-7075

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Nelson Moss, MD

212-639-7075

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • SOTORASIB
  • KRAS G12C
  • CNS-BRAIN
  • Advanced
  • 24-111

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-22.