NCT06934889

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

Phase Ib Trial of ABBV-637 or ABBV-155 in Combination With ERAS-801 for Glioblastoma With Amplification of the Epidermal Growth Factor Receptor

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	ERAS-801	will be administered orally at the assigned dose once daily starting on Cycle 1 Day 1.
DRUG	ABBV-637	will be administered intravenously over one hour (+/- 10 min) once every 28 days on the first day of the new cycle.
DRUG	ABBV-155	will be administered intravenously over at least 30 minutes once every 21 days on the first day of the new cycle.
DRUG	Temozolomide	Temozolomide will be continued for 6 cycles after radiation.
RADIATION	Radiotherapy	will be given as per standard of care radiation for GBM

Timeline

• Start date: 2025-04-07
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2025-04-18
• Last updated: 2026-03-30

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study