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.
Age range
18 Years
Sex
ALL
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Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: Dose-limiting toxicities will be assessed at the end of Cycle 1 (each cycle is 28 days).
Incidence of Treatment-Emergent Adverse Events
Timeframe: Adverse events will be assessed from the first dose through 30 days after the last dose of study treatment, up to approximately 24 months.