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RecruitingGlioblastomaGliosarcoma

Study of ABBV-637 or ABBV-155 With ERAS-801 for People With Glioblastoma

Eligible age

18+ yrs

Accepts

All genders

Locations

6 states

Healthy volunteers

No

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About this study

The researchers are doing this study to find out whether the drugs ABBV-637 and ABBV-155 are safe treatments that cause few or mild side effects when given alone or in combination with ERAS-801 in people with recurrent GBM.

Sponsor: Memorial Sloan Kettering Cancer Center

You may qualify if…

  • Patients must be 18 years of age or older at the time of consent signing.
  • All Patients must have WHO Grade IV Glioblastoma/Gliosarcoma using WHO 2021 criteria and include the diagnosis of molecular GBM, recurrent patients must be progressive or recurrent following radiation therapy +/- chemotherapy
  • Patients must be IDH wild type by CLIA-certified laboratory assay available at time of consent.
  • Patients must have evidence of EGFR gene amplification by CLIA-certified laboratory assay at time of consent.
  • Patients must have measurable disease as per RANO criteria pre-operatively (there is no requirement for post-operative disease to be present or absent). \[cohort A/B only\]
  • Patients must be able to tolerate MRIs
  • Patients may have no more than 2 prior therapy regimens. \[cohort A/B only\]
  • Patients must have recovered from severe toxicity of prior therapy. The following intervals from previous treatments are required to be eligible:

You may not qualify if…

  • Patients may not be receiving any other investigational agents.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the investigational agents are ineligible.
  • Patients with prior therapy with EGFR targeting agents are ineligible because treatment with EGFR kinase inhibitors or other EGFR-targeted agents has the potential to deplete the tumor of EGFR-amplified or EGFR mutant cell populations and confound the evaluation of the investigational regimen. Patients would only be eligible if surgery on a recurrence after the EGFR-targeted therapy confirmed persistence of an EGFR alteration.
  • Patients on enzyme-inducing anti-epileptic drugs (EIAED) are not eligible for treatment on this protocol. Patients may be on non-enzyme inducing anti-epileptic drugs or not be taking any anti-epileptic drugs. Patients previously treated with EIAED may be enrolled if they have been off the EIAED for 10 days or more prior to the first dose of study drug(s).
  • Patients must not have evidence of significant hematologic, renal, or hepatic dysfunctioPatients must not have evidence of significant intracranial hemorrhage (For example, in the recurrent setting, circumstances where the intracranial hemorrhage would obscure the amount and quality of tissue obtained at the time of the on-treatment surgery).
  • Patients with uncontrolled intercurrent illness including, but not limited to, hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements, are ineligible.
  • Participants with clinically significant cardiovascular disease including, but not limited to:
  • No recent history (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.

Where it's recruiting

California

Los Angeles

Florida

Miami

Indiana

Indianapolis

New Jersey

Basking Ridge · Middletown · Montvale

New York

Commack · Harrison · New York · Rockville Centre

Vermont

Burlington

Source: ClinicalTrials.gov · NCT06934889 · last updated 2026-06-10