Evaluating sotorasib for treating brain tumors

BrainMet ADePPT (Anticancer Drug Penetration Platform Trial)

This study tests if a drug called sotorasib can help adults with certain types of brain tumors before they have surgery or a biopsy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 7 sites (Basking Ridge, New Jersey and 6 other locations)
• Trial ID: NCT06807619 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of sotorasib in patients with KRAS G12C+ brain tumors who are scheduled for surgical resection or biopsy. It aims to assess the safety and efficacy of the drug, as well as how the body processes it. The trial includes adult patients with advanced brain tumors and evaluates their response to treatment while monitoring for any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with one or more brain tumors requiring surgical intervention.

Not a fit: Patients without KRAS G12C+ mutations or those not requiring surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS G12C+ brain tumors.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, suggesting potential for success in this novel application.

Eligibility criteria

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

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering West Harrison (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)

Study contacts

• Principal investigator: Nelson Moss, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Nelson Moss, MD

Conditions Brain Tumor; SOTORASIB; KRAS G12C; CNS-BRAIN; Advanced; 24-111