IN10018 in Combination With Dalpiciclib for Progressive Meningiomas

This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment. Participants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 will be taken once daily throughout each cycle, and dalpiciclib will be taken once daily for 21 days followed by 7 days without dalpiciclib. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies. The study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.

NCT Number	NCT07652762
Lead Sponsor	Capital Medical University
Conditions	Meningioma, CDK4/6 Inhibitor
Enrollment	24 participants
Start Date	2026-08
Primary Completion	2028-08 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-08-07