Memorial Sloan Kettering Cancer Center
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.
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.
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-…
will be administered orally at the assigned dose once daily starting on Cycle 1 Day 1.
will be administered intravenously over one hour (+/- 10 min) once every 28 days on the first day of the new cycle.
will be administered intravenously over at least 30 minutes once every 21 days on the first day of the new cycle.
Temozolomide will be continued for 6 cycles after radiation.
will be given as per standard of care radiation for GBM