RecruitingPhase 1NCT06807619

A Study of Sotorasib in People With Brain Tumors

BrainMet ADePPT (Anticancer Drug Penetration Platform Trial)

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

16 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

Brain Tumor

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria8

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

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Interventions

DRUGSotorasib

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