A Study of Sotorasib in People With Brain Tumors

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06807619
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotorasib — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 29, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Nelson Moss, MD
212-639-7075
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Nelson Moss, MD
212-639-7075
Memorial Sloan Kettering Commack (Limited Protocol Activities)CommackNew York11725
Nelson Moss, MD
212-639-7075
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)CommackNew York11725
Nelson Moss, MD
212-639-7075
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)HarrisonNew York10604
Nelson Moss, MD
212-639-7075
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Nelson Moss, MD
212-639-7075
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Nelson Moss, MD
212-639-7075

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