NCT04391595

LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients

A Phase 0/2 Study of LY3214996 (ERK Inhibitor) in Combination With Abemaciclib (CDK4 and 6 Inhibitor) in Recurrent Glioblastoma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Nader Sanai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, multicenter, Phase 0/2 trial that will enroll up to 50 participants with recurrent glioblastoma which are schedule for resection. In the lead-in cohort, a total of 10 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered LY3214996 plus Abemaciclib prior to surgical resection of their tumor. If positive PK results are demonstrated in ≥50% of Phase 0 participants and at least 5 participants are enrolled into Phase 2, up to approximately 40 additional participants will be enrolled in the dose expansion cohort in order to achieve a total of 25 participants enrolled into Phase 2 (lead-in cohort + dose expansion).

Conditions

• Glioblastoma
• GBM
• Glioma

Interventions

Type	Name	Description
DRUG	Abemaciclib	100 mg of Abemaciclib BID for 11 doses over 5.5 days prior to surgical resection. Participants with tumors demonstrating PK-response in Phase 0 will continue treatment with recommended Phase 2 dose (RP2D) continuously in 21d cycles after surgery.
DRUG	LY3214996	400 mg of LY3214996 daily for 6 doses over 5.5 days prior to surgical resection. Participants with tumors demonstrating PK-response in Phase 0 will continue treatment with recommended Phase 2 dose (RP2D) continuously in 21d cycles after surgery.

Timeline

• Start date: 2020-07-11
• Primary completion: 2023-07-27
• Completion: 2025-09-03
• First posted: 2020-05-18
• Last updated: 2026-03-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study