Phase Ib Trial of ABBV-637 or ABBV-155 in Combination With ERAS-801 for Glioblastoma With Amplification of the Epidermal Growth Factor Receptor
Memorial Sloan Kettering Cancer Center
Summary
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.
Description
Stage 1 will run first, during which patients will be randomized to either Cohort A or B if recurrent GBM, and Cohort C or D if newly diagnosed. After these 4 cohorts are complete, and if the combinations have been safe and tolerable, the combination will be further evaluated in Stage 2.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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-…
Interventions
- DrugERAS-801
will be administered orally at the assigned dose once daily starting on Cycle 1 Day 1.
- DrugABBV-637
will be administered intravenously over one hour (+/- 10 min) once every 28 days on the first day of the new cycle.
- DrugABBV-155
will be administered intravenously over at least 30 minutes once every 21 days on the first day of the new cycle.
- DrugTemozolomide
Temozolomide will be continued for 6 cycles after radiation.
- RadiationRadiotherapy
will be given as per standard of care radiation for GBM
Locations (10)
- University of Miami (Data collection only)Miami, Florida
- Indiana University (Data Collection Only)Indianapolis, Indiana
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)Commack, New York