A Study of Sotorasib in People With Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06807619
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nelson Moss, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain Tumor
Study Website: View Trial Website
Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

Commack, New York, 11725

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

Harrison, New York, 10604

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

Uniondale, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

Site Contact

Nelson Moss, MD

[email protected]

212-639-7075

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