This study tests a drug called safusidenib for adults with a type of brain tumor called glioma. Gliomas are graded by the World Health Organization (WHO) based on their severity, with Grade 2 and 3 being less severe than Grade 4. A mutation in a gene called IDH1 is linked to these tumors. The study has 3 parts:
- Part 1: Involves up to 25 patients trying different safusidenib doses to check safety and how the body processes the drug.
- Part 2: Compares safusidenib with a placebo (a fake pill) in about 300 patients. This part is double-blind, meaning neither the patients nor the researchers know who is receiving the drug or placebo.
- Part 3: Involves around 40 patients who had surgery for glioma, testing safusidenib's effect without other treatments like chemo or radiation.
Participants will take safusidenib pills daily and have regular check-ups to monitor tumor response and side effects. The study may continue until the disease progresses or the participant wishes to stop.
- **Study Length**: Continues until disease progression or withdrawal.
- **Visits Needed**: Regular check-ups are required.
- **Risks**: Potential side effects of safusidenib, unknown long-term effects.
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