Study of ABBV-637 or ABBV-155 With ERAS-801 for People With Glioblastoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- ERAS-801
- ABBV-637
- ABBV-155
- Temozolomide
- Radiotherapy
Treatment groups
60 Participants
are divided into 4 treatment groupsLocations
11California
University of California, Los Angeles (Data Collection Only)90095, Los Angeles United States
Florida
University of Miami (Data collection only)33136, Miami United States
Indiana
Indiana University (Data Collection Only)46202, Indianapolis United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920, Basking Ridge United States
Sponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Source ClinicalTrials.gov