Phase Ib Trial of Oral IN10018 Combined with Dalpiciclib for Adults with Growing or Returning Meningioma Brain Tumors

What this Trial Is About

Researchers are studying the combination of IN10018 and dalpiciclib to evaluate its safety, tolerability, and early signs of effectiveness in adults with progressive meningiomas. These tumors grow from membranes surrounding the brain and continue to grow or return after previous treatments. This open-label Phase Ib study aims to find a recommended dose for further research and assess how the drugs affect tumor growth and patient health. Participants will take both study drugs by mouth in 28-day cycles. IN10018 is taken once daily throughout each cycle, starting at 100 mg with a possible reduction to 50 mg if needed. Dalpiciclib is taken once daily at 125 mg for 21 days, followed by 7 days off, with a possible reduction to 100 mg. The study has two parts a dose-confirmation phase using a modified 33 design to find the best dose, and a dose-expansion phase where participants receive the recommended dose. Treatment continues until the tumor grows, side effects become unacceptable, consent is withdrawn, or other stopping reasons apply. During the study, participants will be closely monitored for side effects from the first dose through 30 days after the last dose, up to about 24 months. Researchers will measure tumor response rates, progression-free survival at 6 months, disease control rates, duration of response, and overall survival up to 36 months. Laboratory tests and biomarkers in tumor and blood samples will be assessed to understand treatment effects. Participants will be evaluated regularly to track safety and effectiveness throughout their involvement.

IN10018 in Combination With Dalpiciclib for Progressive Meningiomas