A Study of Sotorasib in People With Brain Tumors

Phase 1

Recruiting

• Conditions: Brain Tumor
• Interventions: Drug: Sotorasib

• Registration Number: NCT06807619
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-29
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DCOI naïve	Sotorasib	Will receive the standard dose of sotorasib.
Progressed on the DCOI	Sotorasib	Will continue to receive the sotorasib dose they were previously receiving, according to their doctor's instruction.

Primary Outcome Measures

Name	Time	Method
ORR (overall response rate)	1 year	defined as the sum of CR (complete response) rate plus PR (partial response) rate, assessed by RECIST 1.1.

Trial Locations

Locations (7)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering West Harrison (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States